Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics...
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FDA
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The FDA recently proposed an amendment to its regulations defining the term “biological product.” The proposed amendment...
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European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
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FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...
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On June 14, 2018, Senator Orrin Hatch of Utah, the co-author of the Hatch-Waxman Act, filed an amendment to the Hatch-Waxman Act in an...
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Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was...
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Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with...
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Last week, Novartis and Amgen announced the FDA approved Aimovig™ (erenumab) for the preventive treatment of migraine in adults. The...
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As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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