Amgen May Face New 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.