Exclusively for subscribers of Biosimilar Development, our content collections bundle articles centered around a particular topic or theme. These carefully curated selections feature content from both our internal team of editors as well as our subject matter experts who contribute regularly to the site.
Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.
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.