Biosimilars Still Flummoxed By Neulasta: Sponsors Now 0 For 2 At FDA
Sandoz announces 'complete response' letter for its pegfilgrastim 351(k) filing, suggesting it’s a tough molecule to crack at the agency.
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Study and formulation requirements under PREA mean that interchangeability application might not be much more of a leap.
FDA says problem with protein misfolding with Sandoz' Enbrel biosimilar candidate unlikely to generate unique toxicity issues in extrapolated indications.
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.