A paper from the brand-backed Alliance for Safe Biologic Medicines disputes the US Food and Drug Administration conclusion that biosimilar switching studies may not be necessary for interchangeability, calling the study supporting it “overreaching.”
Key Takeaways
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The Alliance for Safe Biologic Medicines, which includes brand biologic companies Amgen, Abbvie and Genentech, said in a published paper that an FDA analysis suggesting switching between biosimilars and reference products does not increase safety risks was flawed.
In the paper, published in the Generics and Biosimilars Initiative Journal, Gabi, ASBM wanted to underline “the successes of...