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Home » Biosimilar Guidances Under Review, Sponsor Meetings Continue
Biosimilar Guidances Under Review, Sponsor Meetings Continue
December 16, 2011
Even though the FDA hasn’t released details on how its abbreviated approval pathway for biosimilars will work, the agency has already held 21 pre-IND meetings on 11 reference biologics and received seven INDs, said Leah Christl, CDER’s associate director for biosimilars.