Sandoz Neupogen Biosimilar Heads To ODAC; Cmte. May Be Students As Much As Advisors
This article was originally published in The Pink Sheet Daily
January meeting date suggests FDA’s review of Sandoz’s abridged filgrastim application is on track, but Oncologic Drugs Advisory Committee could be challenged by differences between biosimilar and conventional BLA development.
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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.
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.
Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.