- The Supreme Court on Monday declined to take up a high-profile case brought by Novartis against Amgen over the California biotech's patents on its inflammatory disease drug Enbrel, likely preventing the market entry of lower-cost competition until 2029.
- Novartis had sought to overturn a July 2020 decision by a federal appeals court that affirmed an earlier ruling upholding two key Enbrel patents. Those patents are blocking Novartis from selling a biosimilar, or copycat, version of Enbrel that won Food and Drug Administration approval in 2016.
- First approved in 1998, Enbrel was acquired by Amgen through a 2002 takeover of biotech firm Immunex, the listed defendant in this case. Sales in the 18 years since have earned Amgen over $72 billion, fueled by more than two dozen price increases. Enbrel's wholesale cost now tops $72,000 a year, although that figure doesn't rebates or discounts given to insurers.
Novartis' Enbrel copy, called Erelzi, was one of the very first biosimilars approved in the U.S. Nearly five years later, the would-be competitor remains stuck in limbo due to the powerful patent shields Amgen has constructed around its flagship drug.
The appeal to the Supreme Court was viewed as a long-shot bid by Novartis after the U.S. Court of Appeals for the Federal Circuit ruled for Amgen. With the case's dismissal, Novartis acknowledged the likelihood that it won't be able to launch Erelzi for another eight years, when a key U.S. patent on Enbrel expires.
"Today's decision means Erelzi, a more affordable biosimilar, will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029," said Keren Haruvi, head of Novartis' generic drugs unit, in a statement.
One other biosimilar of Enbrel is approved in the U.S.: Samsung Bioepis' Eticovo, cleared by the FDA in April 2019. But that copycat version is caught up in patent litigation, too, with a district court in New Jersey prohibiting Bioepis from selling the drug.
Biosimilars — essentially generic versions of biologic drugs like Enbrel — were meant to save the U.S. healthcare system billions of dollars through lower-cost competition to top-selling medicines. That's been the case in Europe, where earlier introduction of biosimilars along with government price negotiation has led to steep drops in the cost of several high-profile biologic drugs.
In the U.S., however, more aggressive patenting by branded drug companies delayed or forestalled many biosimilars from launching. And when biosimilars have launched, the peculiarities of drug pricing and rebating in the U.S. have hindered market uptake, biosimilar developers have alleged.
Currently, nearly half of the 29 biosimilars approved by the FDA since 2015 are not yet on the market. Six of those unlaunched biosimilars are copies of Humira, AbbVie's top-selling drug and the highest grossing pharmaceutical product on the market last year. Per settlement deals struck between AbbVie and biosimilar developers, Humira copies are not expected to be available in the U.S. until 2023.
Both Humira and Enbrel work similarly and are approved for many of the same types of inflammatory diseases like rheumatoid arthritis and plaque psoriasis.
For Amgen, the Supreme Court decision is a victory. But sales of Enbrel are already declining, due in large part to competition from other newer, brand-name medicines. The company is now under pressure to prove it can develop a new crop of medicines that can replace its aging top-sellers.