The product is the first pegfilgrastim biosimilar to be authorized by the European Commission and the first Coherus product to be cleared by a regulatory authority.
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.
The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings
September 4th 2024A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings
September 4th 2024A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
2 Commerce Drive
Cranbury, NJ 08512