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Home » Biosimilar Guidances Under Review, FDA-Sponsor Meetings Continue
Biosimilar Guidances Under Review, FDA-Sponsor Meetings Continue
January 4, 2012
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.