FDA Accepts Coherus’s aBLA for Neulasta® Biosimilar

Approved Biosimilar Products  •  Interchangeability  •  Patent Dance  •  Purple Book  •  U.S. FDA News

In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.  Last week, Coherus announced that FDA has accepted its aBLA.   Under the BPCIA, Coherus has 20 days from FDA acceptance to trigger the patent dance by providing the reference product sponsor (Amgen) with a copy of the aBLA and information regarding the processes by which Coherus manufactures its product.

Biosimilars of Neulasta® are already the subject of two BPCIA litigations: Amgen v. Sandoz and Amgen v. Apotex.  Neither Sandoz’s nor Apotex’s products are approved.  This past summer, FDA rejected Sandoz’s aBLA for its pegfilgrastim biosimilar candidate, though Sandoz has stated that it is “ working with the agency to address remaining questions.”  

Stay tuned to Big Molecule Watch for further developments relating to pegfilgrastim biosimilar candidates.

 

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