EU Authorizes Second Pegfilgrastim Biosimilar, Pelgraz

The European Union (EU) today authorized its second pegfilgrastim biosimilar, referenced on Neulasta. The product, to be sold as Pelgraz, is indicated to reduce the duration of neutropenia, as well as the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy.

Accord Healthcare, the developer of the biosimilar, has said that the first countries will launch the product immediately on receipt of their marketing authorization and appropriate national price and reimbursement activities, which will potentially “make Accord the first to market a biosimilar pegfilgrastim in Europe.” Of note, Accord has said that Pelgraz is the only licensed biosimilar treatment in the EU that has phase 3 clinical data in addition to phase 1 as part of its efficacy and safety profile.

“This approval builds on our established expertise and extensive oncology treatment portfolio. We are committed to ensuring that Pelgraz will be made available as each country concludes its regulatory process. We anticipate being first out of production and into the healthcare professional’s hands in most European markets,” said Paul Tredwell, Accord vice president of Specialty Brands, Europe/Middle East/North Africa Regions.

The approval was based on the clinical development program for Pelgraz, which supported its biosimilarity with Neulasta. “This is an important development for the thousands of cancer patients in Europe undergoing chemotherapy who will have greater access to this vital medicine in their cancer treatment journey,” said Paul Cornes, MD, consultant oncologist, Bristol. “Pegfilgrastim is one dose per cycle administration, which may reduce the need for white blood cell count monitoring and patients avoid the potential worry of daily injections.”

This marks the second pegfilgrastim biosimilar approved in Europe in the same week; just yesterday the European Commission granted a marketing authorization for Coherus’ CHS-1701, a pegfilgrastim biosimilar to be sold as Udenyca.