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.
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.
Biosimilars Regulatory Roundup for November 2022—Podcast Edition
December 4th 2022On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.
Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development
September 13th 2023An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.
Regulatory Updates From Around the Globe Provide Hope for Biosimilars
September 9th 2023An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.
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