Biosimilar Non-Medical Switching: Advocacy Groups, FDA Advisors Push For Action
FDA considering public statement reflecting its view that biosimilars not deemed interchangeable will not be substituted at pharmacy, but the extent such a statement would limit payer-driven practice remains in question.
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Biosimilar Advisory Committee Features Actual Debate About Biosimilarity
FDA says problem with protein misfolding with Sandoz' Enbrel biosimilar candidate unlikely to generate unique toxicity issues in extrapolated indications.
Biosimilar Sponsors May Be Going Overboard On Clinical Data, FDA Says
Studying multiple indications 'not the right way to approach biosimilars,' agency says; Amgen conducted more studies than needed for its proposed Humira biosimilar to enhance patient and physician confidence.
Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway
Time and again, FDA officials had to explain the importance of the analytical characterization data in the biosimilar development paradigm.