FDA Accepts Application for Fresenius Kabi's Pegfilgrastim

Fresenius Kabi USA said the FDA has accepted for review its Biologics License Application for the company’s pegfilgrastim candidate (MSB11455), referencing Neulasta.

The application marks the company’s first biosimilar regulatory submission for the US market, although the company has previously announced that it has struck a deal with AbbVie to allow the company to market its adalimumab biosimilar in the United States in 2023.

Pegfilgrastim stimulates the body’s production of white blood cells to fight infection and is employed to reduce the incidence of infection associated with febrile neutropenia, an adverse effect of chemotherapy.

Improving Access for Patients

“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, chief medical officer for Fresenius Kabi USA. Based in Bad Homburg, Germany, the company maintains a North American headquarters and research and development center in Lake Zurich, Illinois.

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.

Clinical trial data included in the BLA application demonstrate that the biosimilar pegfilgrastim is equivalent to the pharmacokinetic and pharmacodynamic profile of the reference product. Fresenius Kabi officials said the safety and immunogenicity profiles are also comparable to Neulasta.

John Ducker, president and CEO of Fresenius Kabi USA, said the company hopes to become a market leader for biosimilars in the United States, building on its accomplishments in other medicines. “In the United States, we offer oncologists the industry’s broadest portfolio of injectable medicines, and we look forward to bringing this experience to producing high-quality biosimilars,” he said.

Fresenius Kabi launched its biosimilar to adalimumab (Idacio) on the German market last year.