Biosimilars Still Flummoxed By Neulasta: Sponsors Now 0 For 2 At FDA
Executive Summary
Sandoz announces 'complete response' letter for its pegfilgrastim 351(k) filing, suggesting it’s a tough molecule to crack at the agency.
You may also be interested in...
Biosimilars' Pediatric Pressures Could Push Them Toward Interchangeability
Study and formulation requirements under PREA mean that interchangeability application might not be much more of a leap.
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.