Big Molecule Watch
November 29, 2017

Updates on Coherus pegfilgrastim and other biosimilar efforts

We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss.  On September 13, Coherus withdrew its motion to stay.  The court subsequently entered a scheduling order, setting a 5-day trial starting September 16, 2019.

Meanwhile, on September 29, the FDA denied without comment a Citizen Petition filed by Apotex requesting that FDA require biosimilar applicants referencing Neulasta® (pegfilgrastim) to conduct comparative clinical efficacy studies in at least one intended patient population, rather than conducting such studies only in healthy subjects.  Coherus had filed a comment requesting that FDA deny Apotex’s petition.

Coherus also stated during its Q3 earnings call that it is prioritizing its ophthalmology franchise, focusing on its Lucentis biosimilar, CHS-3351, and holding off on its adalimumab biosimilar launch until mid-2022, when certain formulation patents related to adalimumab expire.  Coherus is also seeking to expand its efforts in the US market for its etanercept biosimilar, and has filed IPR petitions challenging patents directed to the etanercept protein.


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