In an unusual step, the Food and Drug Administration withdrew a draft guidance that was issued last fall to help companies develop biosimilar medicines that resemble brand-name biologics.
By doing so, the agency acquiesced to concerns expressed in recent months by companies over some of the recommendations that were made for concocting a biosimilar, which is a nearly identical variant of a biologic medicine and is expected to provide the same result in patients.
At issue were debates over such weedy topics as the statistical approach to achieving similarity to biologics and the number of samples needed to evaluate and confirm similarity over time. This is important because brand-name companies sometimes modify their own processes, which can pose significant challenges for biosimilar companies.
In explaining its move, the FDA conceded different approaches are needed. But on a broader scale, the withdrawal reflected hopes of spurring faster biosimilar development. The key reason is that biosimilars are forecast to save the U.S. between $27 billion and $58 billion in health care costs by 2021, according to IQVIA Institute for Human Data Science, the market research arm of IQVIA.
Going forward, the FDA intends to issue future draft guidance that will “reflect state-of-the-art techniques” for evaluating analytical data that can demonstrate a biosimilar is, in fact, highly similar to a brand-name biologic medicine.
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