U.S. Biosimilar Regulatory Progress: Are We Making Progress?

Within the past year, there have been several key developments in the U.S. biosimilar regulatory pathway. In addition to the final interchangeability guidance, the drastically revised comparative analytics guidance, and the impending 505(b)(2) pathway change, ongoing discussions continue to arise around just how much we know and how confident we can be about the science of biosimilarity. Biosimilar approvals in the U.S. are being granted at a quicker pace, but the allure of tailored biosimilar development that lowers or eliminates dependence on large comparative clinical trials remains a long-term, highly sought-after goal. This collection of articles examines several of the FDA’s most recent high-profile guidances and how certain regulatory decisions will (or will not) advance the biosimilar industry.