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.
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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.
Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis
FDA says Sandoz's biosimilar is highly similar to Amgen's Enbrel after Sandoz answered question about data comparing it to US-approved product.
Biosimilars: Does FDA Caution Make Advisory Committee A Rubber Stamp?
Like biosimilar candidates Zarxio and Inflectra before it, Amgen's ABP 501 enters its advisory committee review with FDA's full-throated endorsement.