For Indian drugmakers grappling with uncertainty over potential US tariffs on pharmaceutical imports, there is encouraging news from the US Food and Drug Administration (FDA).
The agency has proposed significant reforms aimed at accelerating the development and approval of biosimilars—generic versions of biologic drugs that are more complex than conventional small-molecule medicines.
In its new draft guidance released on October 29, the FDA has proposed major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. It also plans to streamline the process for designating biosimilars as “interchangeable” with branded biologics, a move expected to make lower-cost alternatives more accessible to patients and pharmacists.
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