Sandoz’s Biosimilar Filing Is Culmination Of Paradigm Shift In FDA Drug Review
FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.
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Oncologic Drugs Advisory Committee’s unanimous endorsement of Neupogen biosimilar amounted to a slam dunk, but other sponsors with more complex biologics and less foreign marketing experience may face greater skepticism from FDA and its experts.
Because FDA agreed data comparing Sandoz’s filgrastim to EU-approved Neupogen could serve as bridge for comparisons to U.S.-approved Neupogen, firm only needed two additional studies for its biosimilar application.
Pegfilgrastim product, a collaboration with the Indian firm Intas, may have to compete with multiple filgrastim products, along with its reference biologic, Amgen’s Neulasta.