Coherus, Accord Both Receive Positive CHMP Opinions for Pegfilgrastim Biosimilars

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug, referencing Neulasta, under the name Udenyca.

Coherus indicated that its data package for the drug included analytical similarity data, a 3-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy volunteers, as well as an immunogenicity package including a dedicated immunogenicity study in more than 300 patients.

"The positive opinion issued by the CHMP today is a significant milestone for Coherus, as it validates both our Udenyca biosimilarity package as well as our development platform as a whole," said Denny Lanfear, president and CEO of Coherus BioSciences, in a statement.

The opinion is welcome news for the biosimilar developer; in 2017, Coherus experienced a setback for CHS-1701 when 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 May 2018, Coherus resubmitted its Biologics License Application in May 2018.

Also today, Accord Healthcare received a positive CHMP opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.

The opinion was based on a phase 1 PK and PD study in healthy volunteers as well as a phase 3 study in patients with breast cancer who were receiving docetaxel, doxorubicin, and cyclophosphamide chemotherapy.

Accord has long-standing experience in the European biosimilars space with its filgrastim biosimilar, Accofil, which was approved in 2014. “Since then the product has been used over 2 million times,” said Binish Chudgar, vice chairman and managing director of Intas Group, Accord’s parent company. “Accord has gained valuable experience in bringing biosimilar medicines to market. Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be a first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz,” he added.

Both products will now await final clearance by the European Commission before they will be authorized for marketing in the European Union and European Economic Area.