FDA Accepts for Review Pegfilgrastim Biosimilar From Fresenius Kabi

The FDA has accepted for review MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, Fresenius Kabi said Wednesday.

It is the company’s first Biologics License Application submission. Last week, the product was also accepted for review by the European Medicines Agency.

If approved, the product would compete against the originator, sold by Amgen. There are currently 3 pegfilgrastim biosimilars on the US market. They include Udenyca (Coherus BioSciences), Fulphila (Mylan/Biocon), and Ziextenzo (Sandoz). Market size for pegfilgrastim is estimated at $3.6 billion.

Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia. It is the long-acting form of filgrastim, a recombinant human granulocyte colony‐stimulating factor. It is administered to patients undergoing myelosuppressive chemotherapy to reduce the risk of developing febrile neutropenia. This condition can force patients to reduce the dose of chemotherapy or discontinue it entirely.

“Pegfilgrastim plays a vital role in oncology care, and this acceptance by FDA is an important step toward giving oncologists and their patients greater access by providing another option to help support the immune system following chemotherapy,” said Seema Kumbhat, MD, the company’s chief medical officer, said in a statement.

The company said that MSB11455 has similar safety and immunogenicity profiles to Neulasta.

Fresenius Kabi is hoping to position itself in the US biosimilar market. In addition to the possibility of MSB11455, the company already has an agreement with AbbVie, maker of Humira, that will allow the company to market its biosimilar adalimumab product in the United States in 2023. The company already sells biosimilar adalimumab in Germany.