Big Molecule Watch
February 2, 2016

Coherus Announces Proposed Neulasta Biosimilar Met Primary Endpoints in Immunogenicity Study

Coherus announced yesterday “a key achievement in support of [its] planned Biologics License Application (BLA) filing” for a proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim): its proposed biosimilar, CHS-1701, has “met both primary endpoints in a double-blind, randomized, two-period, parallel-arm clinical study in 303 healthy subjects.”

If accepted for FDA review, the Coherus application would join those submitted by Sandoz and Apotex on the growing list of applications for proposed biosimilars of Neulasta®.