European Commission Authorizes Coherus' Pegfilgrastim Biosimilar, Udenyca

Coherus Biosciences announced today that the European Commission (EC) has granted a marketing authorization for its pegfilgrastim biosimilar, CHS-1701, which Coherus plans to sell as Udenyca. The product is the first pegfilgrastim biosimilar to be authorized by the EC and the first Coherus product to be cleared by a regulatory authority.

"Today’s EC approval decision is the first marketing authorization for Coherus, an important step forward in realizing our mission of increasing access to biologic treatments to patients globally,” said Denny Lanfear, president and CEO of Coherus.

“We look forward to the anticipated US approval later this year and to executing on a vigorous launch, supported by our strategic manufacturing partners in the United States, meeting the highest product quality and production reliability standards,” added Vince Anicetti, COO of Coherus.

The authorization, which is valid in all EU member states and in the European Economic Area, follows a positive opinion adopted by the European Medicines Agency’s Committee for Human Use in July 2018.

The authorization of the pegfilgrastim product, referencing Neulasta, is welcome news for the biosimilar developer; in 2017, Coherus experienced a setback for CHS-1701 when it received a Complete Response Letter (CRL) from the FDA. The CRL cited a need for a reanalysis of a subset of samples with a revised immunogenicity assay, as well as for additional manufacturing information. In the wake of the CRL, the company terminated approximately one-third of its staff in order to streamline its operating costs as it worked toward resolving the FDA’s concerns.

In May 2018, Coherus resubmitted its Biologics License Application. The FDA is expected to make its decision on the product in early November 2018.