On the heels of positive clinical studies, Fresenius Kabi said the European Medicines Agency will review its product application for a pegfilgrastim biosimilar.
German biotechnology company Fresenius Kabi said the European Medicines Agency (EMA) has accepted its marketing application for the pegfilgrastim biosimilar MSB11455, a version of Amgen’s Neulasta.
The EMA’s decision to review the application marks a new milestone for Fresenius Kabi, which last year gained EMA approval for an adalimumab biosimilar, Idacio, and launched it on the European market.
“This is an important achievement in the development of our entire biosimilar pipeline and oncology portfolio,” said Michael Schönhofen, a member of the Fresenius Kabi management board and president of its Pharmaceuticals and Devices Division, in a statement.
MSB11455 stimulates the growth of white blood cells that are essential to fight infections, a common adverse event in patients receiving chemotherapy for cancer. MSB11455 was developed in Switzerland by Fresenius Kabi’s immunology and oncology research lab there.
The EMA Marketing Authorization Application submission for the pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data. Two pivotal clinical trials were conducted that showed the drug had an equivalent pharmacokinetic and pharmacodynamic profile to reference pegfilgrastim, as well as similar immunogenicity, in healthy volunteers. Company officials said the product’s safety profile also was comparable to pegfilgrastim.
Pegfilgrastim is a long-acting form of filgrastim, a recombinant human granulocyte colony-stimulating factor, or G-CSF, that stimulates the production of neutrophils, or white blood cells. The reference product is approved in the European Union for reducing the duration of neutropenia and the incidence of febrile neutropenia in adult patients.
In a recent report, Fresenius Kabi noted its pegfilgrastim candidate demonstrated safety and immunogenicity similarity to the reference product. Pharmacokinetic and pharmacodynamic equivalence were previously demonstrated for this agent.
Fresenius Kabi also is developing a tocilizumab biosimilar, for rheumatoid arthritis.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.