The FDA has announced action to “make it faster and less costly to develop biosimilar medicines, which are lower-cost ‘generic’ alternatives to biologic drugs that treat serious and chronic diseases.”
The FDA has issued a new draft guidance proposing “major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.” The agency also plans to “make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.”
Biologic medications “make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024. FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%. To date, FDA has approved 76 biosimilars, corresponding to a small fraction of approved biologics. By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.”
The FDA’s new guidance allows developers to rely on “analytical testing” instead of “comparative efficacy studies” in the review process, claiming that those studies take a lot of time and money but “generally have low sensitivity compared to many other analytical assessments.” 76 biosimilars have been approved by the FDA since the approval pathway was set up in 2010.
