Commercialization

When BridgeBio Pharma prepared to sell the heart drug Attruby on its own, investors and analysts were skeptical. The San Francisco-area biotechnology firm was competing with two large companies with experienced sales forces, and its chances of success seemed slim.

Optimistic investors believed BridgeBio, at best, could rake in $100 million in sales for the year. But Attruby easily blew past those projections, earning $362 million in 2025 and proving BridgeBio a viable threat to its bigger rivals.

Now, those analyst notes — the skeptical and the optimistic — are framed in the background of a room in BridgeBio’s San Francisco office, where Matt Outten, its chief commercial officer, sometimes takes meetings. “When people come in, they see the good ones, and also the ones where people are like, ‘you could never do it,’” Outten told BioPharma Dive. “The nice thing is, I'm starting to have to replace the early notes with the positive ones.”

Biotechs spend hundreds of millions, if not billions, to develop a medicine. Most will fail, and those that don’t often end up selling the rights to their drug — or the entire firm — to a partner with the budget and sales force to launch their product. Investors historically bet on those deals and against the companies that try to market their own drugs, a “short the launch” approach built on decades of skepticism.

But over the past few years, more have grabbed at the proverbial brass ring. Among them are companies like Argenx, BridgeBio, Insmed and Madrigal Pharmaceuticals, which have all proven they can sell medicines better than investors expected. In the process, they’ve joined the ranks of the sector’s more valuable companies, rewarding the shareholders who stuck around for the journey.

“For companies with significant products, investors are becoming more willing to tolerate slower launch ramps,” said Michael Rome, a managing director at Foresite Capital.

Biotech companies make many tough strategic decisions early on, from which diseases to target to how to finance themselves. But as they mature, they’ll all confront the critical choice of whether to sell their own drugs.

Forging ahead and succeeding could offer big financial upside, enabling a young drugmaker to grow into a large and profitable company. Yet that’s an expensive undertaking that requires patient investors.

One company facing this question is Alumis, which will apply later this year for approval of envudeucitinib, a competitor to Bristol Myers Squibb’s psoriasis treatment Sotyktu. The biotech’s shares have skyrocketed since it revealed data showing its drug may be not only superior to Sotyktu, but among the best in an emerging class of therapies. That drug is also in testing for other autoimmune conditions such as lupus.

At peak, envudeucitinib could bring in $1.7 billion in annual sales in psoriasis alone, according to one forecast by the investment firm Leerink Partners. But bringing the drug to market would be a costly endeavor, as footing the bill for direct-to-consumer advertising is a difficult expense for a company of Alumis' size to handle, said Martin Babler, Alumis’ CEO.

To “maximize that opportunity,” Babler said, “that is more likely going to be done with a partner than on our own.”

LB Pharmaceuticals is making similar calculations. CEO Heather Turner told BioPharma Dive in January that the company, which has a schizophrenia drug in late-stage testing, is weighing whether it can market its own medicines. In securities filings prior to going public, LB made the case that its drug could outperform approved schizophrenia treatments, among them Bristol Myers’ Cobenfy. "We think it is a nice, large market opportunity, which helps, but it is one in which a biotech company could credibly launch,” Turner said.

Turner was previously the CEO of Carmot Therapeutics, an obesity specialist that eventually sold to Roche for $3.1 billion. Had that company considered marketing its own drugs, “people probably would have laughed at me,” she said.

Still, some are considering doing so. One is Kailera, a well-funded obesity drugmaker that recently raised one of the sector’s biggest-ever initial public offerings. It's advancing a portfolio led by ribupatide, a weight loss treatment that it’s hoping will compete with Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. CEO Ron Renaud — who has led and sold three other biotechs — previously said the company built into its hiring plans the expertise needed to lead future drug launches. At least as of now, the company intends to sell its own medicines one day.

“We’ve got a chief medical officer who has developed blockbuster cardiovascular drugs in the past,” Renaud said. “We have that experience internally. So the idea is to take this as far as we can with the skill sets that we have.” 

Companies with such ambitions have recent positive examples indicating that kind of plan can yield a stable, profitable business investors will buy into. The drug Ohtuvayre was off to an exceptionally fast launch in a kind of lung disease when its developer, Verona Pharma, was acquired by Merck & Co. for $10 billion in 2025. Argenx commands a nearly $50 billion market cap thanks to the sales growth of the immune drug Vyvgart. Others, such as Insmed and BeOne Medicines, are approaching similar valuations thanks to rapidly growing franchises.

Other biotechs are showing they might reach those heights, too.

Madrigal surprised investors with the early sales trajectory of Rezdiffra, the first drug approved for metabolic dysfunction-associated steatohepatitis, or MASH. Prior to that clearance, there was skepticism about Rezdiffra’s benefits and the market potential for MASH drugs.

Yet Madrigal’s first-mover advantage and strong uptake caused sales of Rezdiffra to outstrip analysts’ expectations. The drug reached $180 million in its first year on the market and almost $1 billion in 2025. Along the way, Madrigal’s value soared. Even with a stock decline this year, the company is worth around $12 billion.

BridgeBio, meanwhile, brought a drug for the progressive heart condition transthyretin amyloidosis cardiomyopathy to market when one, Pfizer’s tafamidis, was already available and another, from Alnylam Pharmaceuticals, was soon following. But BridgeBio compiled data suggesting its drug might be more potent than tafamidis and priced the therapy at a discount. It also adopted a series of marketing strategies to “lower the bar” for access, BridgeBio CEO Neil Kumar previously told BioPharma Dive.

“It takes some bravery and Wild West attitude to think that you can do it even when so many other people have not,” BridgeBio’s Outten said.

The uptake of Attruby has accelerated in 2026. BridgeBio is now worth more than $13 billion.

These stories, some analysts say, represent a maturation for the sector that may have been accelerated by a tough environment. Up until late last year, biotech suffered through a lengthy pullback in funding and dealmaking that forced many developers to spend more frugally to survive, said RBC Capital Markets analyst Luca Issi.

According to Issi, these kinds of cost-controlling maneuvers have better prepared companies to profitably sell medicines — positioning them to reward shareholders without agreeing to a takeover.

"Most biotech companies graduate middle school and get bought," Issi said. "These guys graduated college and they have their own jobs. They got their PhDs and MDs."

Mergers and acquisitions are still a core part of the biopharmaceutical sector. Large pharma companies often snap up biotechs to get ahold of new drugs that can grow revenue or offset patent expirations. This year, more than 20 buyout deals have already been struck, the majority of which were worth at least $1 billion, according to BioPharma Dive data.

An April report from Stifel described the fast start as the sector’s second most active year, ever, for M&A.

Issi contends that biotech’s evolution could, at minimum, give younger firms more leverage in deal negotiations. But others also note how there are now enough recent examples of drugmakers successfully launching new medicines to credibly argue that more should try.

“It’s taken longer than I initially thought it would take, but it's a good thing,” said Mani Foroohar, an analyst at Leerink. “The universe of companies that people think of as ‘grown-up,’” he added, “is expanding.”

Those success stories could also make biotech more appealing to the “generalist” investors that have long seen biotech as a crapshoot, RBC’s Issi said.

“There's this perception from generalists that biotech is just like playing in a casino, like you gamble on who gets bought,” Issi said. “But the broader sector is in much better shape because we have more companies that have self-sustainable businesses.”

Patents reward drugmakers for their inventions and, effectively, the large sums of money they invest in research and development. The legal monopoly that patents provide keeps generic copies at bay for many years, even decades, and allows pharmaceutical companies to set higher prices than they otherwise could.

Executive decisions are often closely linked to the patent life of blockbuster medicines. Ahead of so-called patent cliffs, when patent expirations permit waves of lookalike competitors to enter the market, companies typically seek to restock their pipelines by investing in R&D, licensing experimental therapies or acquiring other drugmakers.

A major patent cliff faces the pharma industry this decade, putting more than $200 billion in annual revenue at risk through 2030. This will force companies into major decisions: Will they pour more money into research? Or will they buy their way out of trouble? 

Below, BioPharma Dive has compiled upcoming expiration dates for the key patents protecting the 50 top-selling drugs, by 2025 sales. We’ll be updating this database as the relevant dates and products change. If we’ve missed anything, or there’s any additional information you’d like to see, please reach out and let us know.

The standard term for patents granted in the U.S. is 20 years. Drugmakers usually will have already secured patents on a new drug ahead of any regulatory approval, meaning the protected time on market can be less.

There are strategies to offset this, however, as companies can piece together different forms of regulatory exclusivity, seek what’s known as patent term restoration or create “thickets” of various patents on everything from a dosing schedule to an injection device. 

These thickets — now the target of government scrutiny in the U.S. — can sometimes stave off generic competition for two decades or more. Enbrel, an inflammatory disease drug sold by Amgen, will have enjoyed more than 30 years of protected time on market when a key patent expires in 2029, for example. 

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The U.S. Food and Drug Administration’s (FDA) renewed focus on drug repurposing is bringing fresh attention to the 505(b)(2) pathway, a regulatory mechanism that bridges traditional 505(b)(1) new drug applications and abbreviated new drug applications (ANDAs). Over time, sponsors have increasingly adopted the pathway as its strategic advantages became clearer and FDA expectations evolved. 

For drug developers, 505(b)(2) can accelerate FDA approval. However, discussions often focus on predicate data and regulatory strategies while overlooking the needs of U.S. payers. This can create a disconnect at launch, when developers expect broader access and lower patient out-of-pocket costs than payers are willing to support. 

We spoke with national payer pharmacy decision-makers about how they evaluate 505(b)(2) products and whether FDA approval alone is enough to secure strong market access. Here’s what they shared. 

De-mystifying the payer evaluation process of 505(b)(2)s 

A drug developer’s 505(b)(2) product is approved by FDA. With label, product dossier and a collection of supporting clinical papers in hand, the drug developer engages payers on formulary coverage which is often met with:

• A request to return in 6 months. Some payers will ask the drug developer to come back when it is time to review the therapeutic category, often in 6 months, or worse, after the developer has a year’s worth of market experience.  

• Non-preferred coverage. Other payers will cover the drug as a non-preferred product with a combined high rebate and out of pocket patient cost.   

• No coverage. Some payers will not cover the product at all.   

This process can take upwards to 18 months to secure reasonable payer coverage.  

Improving the probability of success 

When asked about a better approach to market access, our payer panel stressed the importance of understanding how payers evaluate 505(b)(2) products. 

The process begins with a simple question: What is the value of the product? Payers assess value in terms of patient care, not FDA approval alone. Although FDA approval is necessary, it does not determine coverage decisions. 

Payers first review the FDA approval package, including the indication, clinical trial design, efficacy and safety data and dosing and administration requirements. This assessment helps them understand the strengths and limitations of the evidence and evaluate how the product may perform in real-world practice. 

The goal is to determine whether the product addresses an unmet medical need and offers a meaningful advantage over existing therapies, including the original product. 

After initial review, the evaluation becomes more focused. Payers assess a core set of clinical, economic and access considerations that help determine formulary placement and coverage. See a representative list of questions below.   

Efficacy 

• What is the efficacy of the 505(b)(2) compared to the original? Is it better and clinically meaningful?   

• Is the improvement to the original product clinically necessary or appropriate?   

• Are there any red flags with the prospective trials?  

Safety 

• What is the safety profile of the original product versus the 505(b)(2)?   

• What are the differences between the original and the 505(b)(2)?   

• Are there any new safety issues to consider?  

Dosing and administration 

• What is the daily dose? If the dose has changed, what patient population benefits and is it clinically necessary or needed?   

• Is the 505(b)(2) easier to use versus the original product?   

• What is the duration of the therapy, and does it require special administration or monitoring?  

Uniqueness of the product 

• Is the market completely genericized or are there brands?   

• Does the 505(b)(2) provide a step-change in care? If so, is it incremental and does it eliminate the need or use of other products or interventions?   

• How differentiated is the product versus other products in the therapeutic category?   

• What is the volume of use of the original product and how does it compare to competition in the category? If low, why is the 505(b)(2) better than original?   

Target population/place in therapy 

• Who is the target patient population and is it different than the original product?   

• Is the product intended for a broad population or segment?  

• Where does it fit in treatment and how long is it used?  

Cost impact 

• What is the impact on the cost of care?   

• If the category is genericized, why is the increased cost of the 505(b)(2) needed?   

• Is the 505(b)(2) priced reasonably?  

Early planning: The key to success 

Achieving FDA approval on a 505(b)(2) product is a significant milestone. But this is only a step on the path to launching a successful product. While payers are not the only end customer, they have a tremendous impact on adoption by HCPs and patients. For 505(b)(2) developers, it is important to factor in the needs of the payer at the pre-IND stage. Consider the questions above as a starting point, not an ending.  

A new round of pricing deals between the White House and pharmaceutical companies will have negligible effects on sales and profits for the industry while offering relief from government threats, Wall Street analysts said.

In December, President Trump announced agreements with nine more drugmakers that he said would significantly lower the prices of prescription medicines. 

The companies each made separate deals to offer discounts on specific drugs, many of which were already heavily rebated or nearing the end of their exclusivity. In return, the companies will receive three years of relief from Trump’s tariffs.

The deals amount to “another round of pandering on carefully selected drugs,” William Blair analyst Matt Phipps wrote in a note to clients. While the medicines will be offered at discounts for those who pay cash, there’s unlikely to be a significant difference in net prices, he said. The cash prices will likely be well above typical co-pays, meaning people with insurance will buy drugs the same way as in the past.

Indeed, one of the companies involved in the latest round of negotiations, Gilead Sciences, said it expects “the financial impact to be manageable in 2026 and beyond.” That’s likely true of all nine deals, Phipps said, telling clients he does not expect “significant impacts on the companies’ growth prospects.”

For their part, investors continue to push pharmaceutical and biotech stocks higher. Pharma and biotech indexes rose for much of 2025, since dipping last April as Trump threatened the industry with “major” tariffs. The threats led to a flurry of announcements of planned investments in U.S. manufacturing, but in the end the tariffs came with exemptions that significantly blunted their impact.

The latest deals are part of Trump’s push to bring “most-favored-nation,” or MFN pricing to pharmaceuticals. The idea is to align costs for U.S. consumers with those in countries that have price controls. In July, Trump sent letters to 17 large drugmakers giving them 60 days to lower prices or face government action.

Pfizer, AstraZeneca, Eli Lilly, Novo Nordisk and EMD Serono previously struck deals with the White House before December’s batch of agreements with Gilead, Merck & Co., Amgen, Bristol Myers Squibb, GSK, Novartis, Sanofi, Genentech, and Boehringer Ingelheim. Johnson & Johnson and AbbVie followed in early 2026.

In addition to specific drug pricing deals, the White House claimed the agreement will “ensure foreign nations can no longer use price controls to free ride on American innovation by guaranteeing MFN prices on all new innovative medicines the nine companies bring to market.”

It’s unclear how that provision will be enforced. And at least one company, Bristol Myers, said its deal means it “will not be subject to future pricing mandates.” The agreements also appear to have offered additional special enticements, with the Food and Drug Administration announcing national priority vouchers for speedy reviews for two Merck experimental drugs on the same day.

The lack of transparency on the negotiations has led Democrats to cry foul. Four top lawmakers sent letters to AstraZeneca, Lilly, Novo and Pfizer seeking information. “Skepticism and scrutiny are warranted as the Trump Administration has repeatedly made announcements that fail to meet their stated goals and instead only increase costs on the consumer,” they said.

President Trump turned his attention to generic drugmakers in July, threatening them with 200% tariffs within three years if they don’t move production to the U.S.

In a Truth Social post, Trump said he would impose 100% tariffs on generic drugs brought into the U.S. starting on Aug. 1, 2028 and 200% thereafter. “This is done in order to RESHORE Generic Pharmaceutical Production into America, with a penalty to those Companies that decide not to build Plant and Equipment within the stated period of time,” Trump said.

Trump offered no details on the policy’s legal justification, how it would be implemented or whether it would affect only finished drugs or the importation of ingredients that generic drugmakers use to manufacture the products that go to consumers. The Supreme Court in February ruled that Trump does not have the ability to unilaterally impose tariffs.

Trump has spent much of his presidency using the threat of levies to extract concessions from the pharmaceutical industry. Makers of brand-name medicines have rushed to announce U.S. investment deals over the last year or so, pledging to spend tens of billions of dollars on U.S. manufacturing facilities.

Seventeen drugmakers also bowed to Trump’s pressure on pharmaceutical pricing, entering “most favored nation” deals that gave them tariff relief in return for promises about lower prices for U.S. consumers. But the agreements involved small numbers of medicines — including ones that already faced generic competition — and have resulted in limited savings for consumers.

The difference for generic drugmakers is that they have much smaller profit margins, so even token concessions would have an outsized effect on the industry. Products could be discontinued or face shortages, and cost cutting to address tariffs might jeopardize the quality of generic drugs, according to a Brookings report issued last year.

The Association for Accessible Medicines, an industry trade group, said generic drugmakers face a number of hurdles as they try to offer lower-priced medicines.

“Our industry has grown significantly in the U.S. over the past two years through targeted investments across the supply chain,” the group’s president and CEO, John Murphy, said in a statement. “However, structural problems in both purchasing and reimbursement for many generic drugs remain a significant inhibitor to the growth of this sector in the U.S.”

Murphy said the trade group still needs to understand what specifically Trump is proposing. But it has ideas for how to address “market deficiencies” and looks forward to talks with the Trump administration and Congress on ways to “restore the generics industry to growth and to prioritize its place as a critical national security asset here in the U.S,” he said.

The actual effects of a new generic drug tariff policy would depend greatly on the details, Jefferies analyst Dennis Ding wrote in a note to clients. If the levies only affect finished products and not the importation of ingredients, companies such as Amphastar Pharmaceuticals and ANI Pharmaceuticals would be the most insulated, while a company like Apotex would have more risk, he wrote.

Advisers to the Food and Drug Administration have endorsed lifting restrictions that stop specialized compounding pharmacies from making certain peptides, heightening the chance that the agency could formally change its stance even as questions linger about their safety and effectiveness.

In closely contested votes, a narrow majority of panelists recommended adding six peptides to the “503A Bulks List,” a registry of ingredients compounders can legally use to make custom medications for individual patients. Two peptides, KPV and TB-500, were being evaluated for use in wound healing, while BP-157 and MOTs-C were considered for ulcerative colitis and weight loss, respectively. Advisers also sanctioned Semax for migraines and pain and the peptide Epitalon for insomnia. 

Safety concerns led the FDA to ban these peptides, which haven’t been rigorously tested for their purported uses, three years ago. But they’ve since soared in popularity among wellness influencers, been embraced by Health and Human Services Robert F. Kennedy Jr. and are sold on the grey market. The FDA usually, but not always, sides with its advisory committees. The only peptide the panel voted down was emideltide, which was being proposed for opioid withdrawal and certain sleep disorders.

The two-day advisory panel meeting in July represented an unusual and high-profile collision between career FDA scientists, medical experts and supporters of a key part of the “MAHA” agenda.

Kennedy has told podcaster Joe Rogan that he’s a “big fan” of peptides and has used them personally. He’s also advocated for widespread use of peptides, as reclassifying them would allow compounding pharmacies to produce higher quality versions than the “research grade” products many Americans are purchasing from questionable sources in search of weight loss, muscle gain or shinier skin.

Yet the peptides in question don’t have substantive proof of efficacy or safety — and do, in some cases, have reports of dangerous side effects. In briefing documents filed ahead of the meeting and during presentations, agency reviewers advised against broader use of those peptides given the lack of available evidence and resulting unknowns about their true risks and benefits.

Additionally, in unusual fashion, the advisory panel included several members with conflicts of interest, such as a history of prescribing or selling peptides. Their presence, as well as the FDA’s initial move in April to schedule the meeting, added to persistent angst that politics and ideology are influencing the agency’s decisionmaking.

The meeting’s outcome isn’t likely to calm those fears. Each vote was close, with a divided panel narrowly recommending broader use or, in emideltide’s case, advising the FDA to exclude it from the 503A Bulks List. Those clashes involved weighing the risks of broader use against keeping the status quo in place.

Supporters — many of whom had ties to peptide-linked businesses — pointed to either an absence of clearly established safety issues or the chance to give patients a more regulated choice than what’s available.

“There's stuff happening out there that we need to try and control and make sure that we keep patients as safe as possible,” said panelist Haleem Mohammed, a physician and Chief Medical Officer of Gameday Men’s Health, a network of clinics that offers peptides.

Dissenters, meanwhile, felt positive votes might cause bigger problems.

“I'm concerned that we're responding to a market-induced demand rather than a decision based in solid science,” said Elizabeth Rebello, the executive director of Anesthesiology, Critical Care and Pain Medicine at University of Texas MD Anderson Cancer Center.

Brian Lee, an associate professor of medicine at USC’s Keck School of Medicine, voiced worries about patient safety and the precedent being set by the proceedings. “I think this endorsement can be potentially harmful, and I cannot, in good conscience, vote yes,” he said regarding opening up use of the peptide BP-157.

Lee also called on the FDA to “standardize” decisionmaking on these products going forward, arguing that such decisions “should be objective and based on facts, not subjective and based on opinion.”

Novo Nordisk is now offering its popular obesity drugs on Hims & Hers’ telehealth platform, ending a messy dispute that resulted in a lawsuit and a crackdown by U.S. drug regulators. 

Under a deal announced in March, Hims said it would provide access to Novo’s GLP-1 medicines — the diabetes drug Ozempic and the injectable and pill forms of the weight loss therapy Wegovy — to U.S. consumers at the same prices as other telehealth firms. Hims also agreed to no longer promote “compounded” versions of GLP-1 drugs on its website or in advertisements, and give existing patients the chance to switch to FDA-approved alternatives.

Novo, as a result, dismissed its patent infringement lawsuit against Hims while “reserving the right to refile in the future.” 

“This agreement with Hims & Hers is a meaningful win for patients in the United States,” said Novo CEO Mike Doustdar in a statement. “By expanding access through leading telehealth providers and digital care platforms, we are helping to connect more people with our FDA-approved medicines, which have been evaluated for safety and efficacy.”

The agreement represented an about-face for Hims, which had, been taking an adversarial stance against the makers of branded weight loss medicines. 

Hims is one of many telehealth firms that have used legal loopholes to capitalize on the demand for GLP-1 weight loss drugs. These firms started making lower-cost, compounded versions of Novo’s injectable Wegovy and Eli Lilly’s rival Zepbound when those medicines were in short supply. But despite lawsuits and warnings from the FDA, those efforts have continued even after the end of those shortages, as compounders have used methods of personalizing treatment regimens to try to comply with federal laws. 

Hims stepped up those plans in February, when it revealed plans to launch a compounded version of the pill form of Wegovy. The FDA approved Novo’s drug in December, making it the first pill of its kind available for obesity. And since then, early prescription totals suggest it’s gotten off to a very fast start. That progress is important for Novo, which has seen its market share eroded by compounders, pricing pressure and competition from Lilly. 

Hims attempted to quickly undercut Novo by selling a knockoff at a lower price. In doing so, Hims claimed that its copycat of oral semaglutide — the active ingredient in Wegovy — was formulated differently and involves a different delivery method to protect it during digestion. Some Wall Street analysts expressed skepticism about those claims, as Novo uses a specialized technology to ensure the effectiveness of its pill, which is a complex “peptide” drug instead of a standard small molecule. 

The move immediately spurred backlash from federal regulators and a lawsuit from Novo, prompting Hims to abandon the effort within days. It’s since completely changed course, calling the Novo deal “part of a new strategy” that’s based on providing U.S. customers with access to a “broad assortment” of FDA-approved counterparts. Compounded versions would only be offered if a clinician determines it’s “clinically necessary,” Hims said. 

Hims, for its part, said the decision is a result of industry progress in making branded GLP-1 medicines “available at more affordable prices,” which has upped demand. 

“We see tremendous growth opportunities in the U.S. with the expanding assortment of branded GLP-1 medications,” said co-founder and CEO Andrew Dudum in the company's statement.

The Trump administration in February unveiled a new online portal that, at the outset, allowed people to purchase around 40 drugs from a handful of manufacturers that have struck pricing deals with the White House.

Dubbed TrumpRx, the platform offers many medications already available through drugmakers’ own direct-to-consumer channels, such as Eli Lilly and Novo Nordisk’s obesity treatments Zepbound and Wegovy. Drugs from Pfizer, Merck & Co. and AstraZeneca, as well as an IVF treatment from EMD Serono, are also offered through the website. 

The products involved have all been featured in “most favored nation” pricing agreements meant to equalize U.S. drug costs with the lowest rate charged overseas. While the service could offer some financial relief to people who pay cash for drugs, it will have little effect on the vast majority of people whose medications are covered by health insurance.

Direct-to-consumer drug sales, which bypass traditional methods of paying for pharmaceuticals, represent a small but growing part of big drugmakers’ marketing strategies.

In the past, pharmaceutical companies used these channels as tools to compete with lower-cost generics. But they’ve become more prominent amid pressure from the Trump administration and, more recently, demand for obesity medications that are frequently excluded from private insurance plans. 

TrumpRx is the latest example. In its announcement, the Trump administration highlighted a dozen medicines that will be sold on the site, most of which are for common conditions like obesity, diabetes, asthma, eczema, infertility and osteoporosis. Aside from obesity drugs, Novo’s version of Wegovy for diabetes, called Ozempic, and AstraZeneca’s lung disease medicine Bevespi Aerosphere were the best-selling products included in the White House’s pricing deals. 

More drugs will be added to the site “in coming months,” the administration said.

Drug companies that cut deals with the White House gained a three-year reprieve from pharmaceutical tariffs in return. Notably, those agreements also largely include medicines that aren’t big earners, are already heavily rebated, or are nearing the end of their exclusivity. And the discounts offered, in many cases, don’t represent a better deal than securing drugs through insurance plans, premiums for which are spiking under the current administration. 

“TrumpRx is nothing more than a glorified coupon book, and it will advance the Republican agenda to undermine affordable health care for American families,” said Ron Wyden, D-Ore., in a statement. 

Eli Lilly in August filed six new lawsuits as part of an effort to combat black-market sales of one of its still-experimental obesity medicines.

The drug, called retatrutide, has delivered powerful results in Lilly’s research to date, in some cases offering weight loss on par with bariatric surgery. But the company is still compiling data and doesn’t even plan to submit an application for Food and Drug Administration approval of the medication until next year.

In the meantime, some people have been so eager to get their hands on retatrutide that they are resorting to online merchants, clinics, compounders and foreign companies that purport to offer a version of Lilly’s product. The substances in this black market could be fake, impure or mis-dosed, posing a myriad of dangers to consumers, Lilly said.

Lilly is seeking the help of courts, regulators and law enforcement agencies at a time when top U.S. health official Robert F. Kennedy Jr. appears inclined to give a freer rein to unreviewed substances in the medical marketplace. In July, an FDA advisory panel endorsed broader use of six peptides for various ailments without substantial evidence of their safety and effectiveness.

Lilly’s fight has also been made more difficult by the increasing use of pharmacies and companies that offer compounded versions of obesity medicines. They rose to prominence in the early days of the GLP-1 drug explosion, when Lilly and rival Novo Nordisk couldn’t keep up with demand, and have continued to steal market share even after the FDA proclaimed the shortage over and told them to stop sales.

The increasing trend of consumers searching for treatments outside the traditional medical system is dangerous, Lilly said. In the case of retatrutide, no regulatory agency anywhere in the world has approved the medicine. “Yet black-market sellers and businesses posing as legitimate medical providers openly sell retatrutide as a weight-loss ‘hack,’” Lilly said. 

“These `medical spas,’ `wellness clinics,’ and self-styled suppliers are not practicing medicine; they are selling illegal drugs,” the company added.

Lilly said it has already referred more than 200 people and entities to regulators, professional licensing boards and law-enforcement officials as a result of the black-market trade. It’s also flagged more than 14,000 websites, ads, social media posts and product listings in over 100 countries.

The entities offering retatrutide aren’t all “shadowy online vendors,” CBS News reported in June. CBS found dozens of professional clinics advertising the drug along with compounding pharmacies, including Striker Pharmacy, one of the entities now being sued by Lilly.

Lilly also sued Aesthetic Envy, Astra Peptides, Legendary Peptides, Texas Peptides and Lone Star Peptide, targeting several for claims that they sell retatrutide for “research use only” products.

Legendary Peptides had no immediate comment on the lawsuit. Representatives for the other five companies didn't immediately respond to requests for comments.

Since the Food and Drug Administration approved the first biosimilar 11 years ago, more than 80 biosimilars for various brand-name drugs have been given the go-ahead, reflecting a shift in regulatory and industry priorities.

Now, the agency is paving the way for more approvals, hoping the smoother road will introduce competition and lower prices for consumers. In March, the FDA issued draft guidance that, in some cases, would lower the bar for biosimilar testing, allowing companies to develop copycat versions of biologic medicines with reduced upfront R&D costs.

Biosimilars aren’t easy to make. Unlike small molecules, which can be recreated using a chemical recipe, biologics and biosimilars are developed with live organisms. Even if a brand-name biologic is well established, biosimilars need to be developed from the ground up and proven to be comparable — and at best interchangeable — with the original.

Comparative studies alone can take up to three years and cost $24 million, according to the FDA. But now, the agency plans to allow biosimilar makers to use data from a comparator product outside the U.S. Copycats have been more prominent in Europe, for example, where regulators have approved more than 130 biosimilars as of last year. This shift could cut development costs by about half, the agency said.

Biosimilars originally gained a pathway to approval as part of the Affordable Care Act in 2010, but their use has been uneven. With limited access to formularies and rampant patent barriers from brand-name drugmakers, the intended effects on prices have been limited.

But there’s also evidence that biosimilars can play a bigger role in the market moving forward if given continuing incentives from regulators.

A future in oncology

Because of a long, difficult and expensive R&D process, biologics come with a hefty price tag. Although they represented only about 5% of prescription volume in 2024, biologic medicines made up more than half of all drug spending in 2024, according to a recent report from health services company Cardinal Health.

Biologics have dominated in oncology since the arrival of “checkpoint inhibitors” in the middle of last decade. Those drugs are now used to treat dozens of cancers, in turn, have become big business for Big Pharma.

Merck & Co.’s cancer drug Keytruda remained one of the world’s bestselling drugs last year, raking in more than $35 billion.

Cancer drugs like Keytruda, as well as Bristol Myers Squibb’s Yervoy and Opdivo, and Genentech’s Perjeta, face exclusivity losses before 2030, opening the door to biosimilar competition. This wave could potentially result in major savings, Cardinal Health reported.

Oncologists have also been the most receptive to incoming biosimilars, with 99% of practices saying they are “confident in explaining biosimilars to patients,” according to Cardinal Health, which could drive demand and encourage patient switches.

Biosimilars of Roche’s Herceptin provide an early example of cost savings in cancer. Six copycats of the breast cancer drug have entered the market since 2019, resulting in an average sales price drop of 76%, Cardinal Health found.

Some price cuts, however, make for an unsustainable market for biosimilar makers. For example, when biosimilars of AbbVie’s bestselling immunology drug Humira entered the market in 2023, some launched at a 92% discount from the brand name’s wholesale acquisition cost, according to the Association for Accessible Medicines’ Biosimilars Council, creating difficult margins.

AbbVie’s legal practices presented another barrier for competitors. A “patent thicket” of hundreds of protections surrounding Humira kept biosimilars from the market for years until the pharma giant achieved settlements with the copycat makers for a 2023 launch. The biosimilars struggled at first before gaining traction about a year later.

While some biosimilars do cut costs for patients, the margins for companies that make them have become too thin. At the rate of $100 million to $300 million in upfront investment and years of clinical development, “fewer manufacturers will be able — or willing — to bring new biosimilars to market. This means the U.S. market could face diminished competition and higher long-term costs for patients,” according to the Biosimilars Council.

That’s where regulatory changes like the FDA’s revamped guidance could come into play. Big biosimilar makers like Amgen, Pfizer and Sandoz could reap the benefits of an easier route to market, potentially lowering prescription drug costs if the barriers to entry are reduced.

The federal government announced the next 15 medicines for which it will seek price reductions with the help of Medicare’s new negotiating power, including the breast cancer drugs Kisqali and Verzenio and the HIV treatment Biktarvy. Those cuts, which are allowed through the Inflation Reduction Act, will go into effect in 2028. 

Also included in the third annual round of price negotiations were the rheumatoid arthritis medicines Orencia, Cimzia and Xeljanz, as well as Botox when it’s used for therapeutic purposes like migraines. The Centers for Medicare and Medicaid Services designated these drugs for price negotiations under IRA provisions meant to limit expenditures on the drugs associated with the program’s highest costs. 

Combined, the 15 drugs account for $27 billion in Medicare spending and are used by some 1.8 million enrollees. Eli Lilly’s weekly GLP-1 shot for diabetes, Trulicity, is associated with $4.9 billion in annual costs, the highest of any medication on the list.

“CMS is taking strong action to target the most expensive drugs in Medicare, negotiate fair prices, and make sure the system works for patients — not special interests,” said CMS Administrator Mehmet Oz, in a statement. “This approach delivers real savings while strengthening accountability across the program.”

For the first time, these negotiations will include medicines covered by its “Part B” program that involves drugs administered in a physician’s office or other healthcare facility. Orencia, Cimzia and Botox are three examples. 

However, two key drugs that had been previously been expected to make this year’s list — the widely used cancer immunotherapies Keytruda and Opdivo — were left off. The inclusion of both was delayed by at least a year through provisions of the One Big Beautiful Bill Act, which changed the way the IRA program is applied to certain drugs.

The price cuts will, as a result, be “immaterial” for most of the companies whose drugs are on the list, according to Leerink Partners analyst David Risinger. The one exception is Biktarvy, which has Medicare revenue that could represent 8% of Gilead Sciences’ 2027 sales, Risinger wrote in a note to clients.

The exposure for all of the other companies involved comes to 3% or less of overall revenue, Risinger wrote.

Nonetheless, the industry group Pharmaceutical Research and Manufacturers of America railed against the announcement. The group argued that the IRA is “undermining future medical progress” by discouraging investment in new drugs, particularly the chemical, or “small molecule,” drugs that are subject to IRA price negotiations sooner than biologic medications.

“CMS is now planning to set prices for additional small molecule cancer treatments that would otherwise be spared without this penalty – driving even more investment away from these critical treatment options,” said Elizabeth Carpenter, the group’s executive vice president of policy and research, in a statement.

The first round of price negotiations, conducted in 2024, took effect this year.