- Claiming biosimilar drugs are inferior to their branded competitors may violate both consumer protection and antitrust laws, a top Federal Trade Commission official said Monday.
- Tara Koslov, chief of staff to FTC Chairman Joseph Simons, said the agency will also closely watch drugmaker activities that could delay competition, such as patent agreements in violation of antitrust laws.
- The Food and Drug Administration, meanwhile, has seen "publication of materials that seemed designed to create uncertainty about biosimilars," according to Commissioner Stephen Hahn, speaking at a joint workshop with the FTC. Hahn added that these materials could prevent the lookalike drugs from achieving their potential of lowering healthcare costs.
The first biosimilar approved through the modernized FDA review pathway was cleared by the regulator almost exactly five years ago — Novartis' Zarxio, a competitor to Amgen's Neuopogen.
Yet biosimilars have not had the impact in the United States that they've had in Europe, where approval has yielded sharp decreases in prices. For example, AbbVie's Humira faced discounts as steep as 80% in some European countries when biosimilars arrived in 2018. The top-selling drug won't face competition in the U.S. until 2023.
The makers of branded biologics could take actions to discourage biosimilar competition, ranging from business practices that impede market entry to advertising that claims the original brand is superior, Hahn and Koslov noted in speeches at the joint agency workshop.
"These behaviors have the potential to put innovation at risk, erode public confidence in the product, weaken efforts to lower health care costs through competition, and ultimately undermine advances in health care," Hahn said.
Claiming biosimilars are inferior could violate the law in two ways, Koslov said. One is by breaching consumer protection laws: "Advertising that creates an impression of clinically meaningful differences between a reference biologic and its biosimilar is likely false or misleading, and therefore would constitute an unfair or deceptive practice," she said.
The other is an antitrust claim, as countering misleading advertising creates "artificial barriers to entry and creates costs for biosimilar manufacturers."
The FTC will also closely review legal settlements between branded drugmakers and biosimilar rivals to determine if there has been any payment or remuneration in order to delay entry — the so-called "pay-for-delay" deals used in the small-molecule market, Koslov said.
In addition, the agency will watch for other tactics that could hold up biosimilar development, such as restricting access to samples of branded biologics that are necessary for analyzing comparability. The FTC and New York attorney general recently brought a claim against Vyera Pharmaceuticals for restricting access to samples of the small molecule drug Daraprim, and the FTC will look at doing the same in the biologics sector.
Hahn and Koslov did not address another complaint about barriers to biosimilar entry, that of contracts designed to unfairly secure favorable insurer coverage when biosimilars launch. Pfizer sued Johnson & Johnson over such a claim when it launched Inflectra, a biosimilar to J&J's Remicade.