The Food and Drug Administration (FDA) is taking major steps to speed up the approval and reduce the cost of biosimilars—generic versions of complex, expensive biologic drugs used to treat diseases like cancer and arthritis. However, industry experts warn that these efforts may be nullified by the U.S. Patent and Trademark Office’s (USPTO) actions, which are making it harder to challenge the patents that protect brand-name biologics.
The FDA’s Streamlined Approach
FDA Commissioner Marty Makary announced a plan on October 29th to regulate biosimilars more like traditional generics, which are copies of simple chemical pills. The primary goal is to halve the time and money required to bring a biosimilar drug to market. This change in approach could save developing companies up to $100 million per drug, according to Stefan Glombitza, CEO of Formycon AG.
The new guidance formalizes recent FDA practices that waive expensive requirements. Specifically, companies can now use less costly analytical tests to show that a biosimilar has no clinically meaningful difference from the brand-name drug, moving away from expensive, large-scale patient trials originally contemplated under a 2009 law. The FDA is also moving away from requiring “switching” tests, in which patients switch between the brand-name drug and the biosimilar. While many states require these studies for a biosimilar to obtain “interchangeable” status—which allows pharmacists to substitute the cheaper version—the FDA no longer deems them necessary for initial approval.
Patent Hurdles and the USPTO
Despite the FDA’s helpful guidance, biosimilar manufacturers argue that patent protection is the most significant barrier they face, often eclipsing FDA regulation. Brand-name biologic makers commonly file scores or even hundreds of patents on a single drug, creating a “patent thicket” that ensures delays. Legal battles, known as the “patent dance,” can stall market entry for years. For instance, while the first biosimilar for the rheumatoid arthritis drug Humira was approved in 2016, competitors did not hit the market until 2023 due to persistent patent challenges.
Biosimilar makers are charging that the USPTO, under the current administration, is working at “cross-purposes” with the FDA by restricting a key mechanism for challenging patents called “inter partes review” (IPR). IPR is a sped-up process used to invalidate brand-name patents, but the administration has recently denied most IPR requests and proposed rules to make them even harder to obtain. This makes U.S. patent challenges 10 to 20 times more expensive than in Europe, hindering companies like Formycon, even after receiving FDA waivers for clinical trials.
Why Biosimilars Matter
Biologic drugs account for only 5% of prescriptions but consume over half of the nation’s $600 billion annual drug spending, making biosimilars crucial for cost reduction. They can cost up to 90% less than their brand-name counterparts.
However, even when biosimilars launch, they struggle to gain traction. Humira biosimilars, for example, accounted for only about a quarter of sales in 2024, despite their significantly lower price tags. This slow adoption is often attributed to brand-name companies offering lucrative rebates to pharmacy benefit managers (PBMs)—the middlemen who design insurance formularies—which disincentivizes the use of the cheaper biosimilars.
For patients like Judy Aiken, who saw her out-of-pocket costs reduced by recent legislation, the promise of biosimilars is critical, but the lack of market access due to patent machinery remains the biggest roadblock. Only about 10% of the 118 biologics set to come off patent in the next decade have biosimilars in development, reflecting poor incentives in a system that is stacked against them.
Source: Medical Marketing & Media | November 17, 2025
