FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar

LAKE ZURICH, Ill., May 27, 2020 - Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, announced today the U.S. Food and Drug Administration has accepted for review the company's Biologics License Application (BLA) for MSB11455, the company's pegfilgrastim biosimilar candidate for Neulasta^®.

This is Fresenius Kabi's first U.S. biosimilar regulatory submission. Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy. The drug works by stimulating the body's own production of white blood cells to fight infection.

"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, M.D., chief medical officer for Fresenius Kabi USA.

Fresenius Kabi has global expertise in the development, manufacturing and distribution of generic pharmaceuticals with a focus on quality, reliability of supply and responsive customer and patient support.

"The acceptance of Fresenius Kabi's submission of pegfilgrastim marks a key milestone as we seek approval for our first biosimilar in the United States," said John Ducker, president and CEO of Fresenius Kabi USA. "Fresenius Kabi is well positioned to become a U.S. market leader in biosimilars. In the U.S., we offer oncologists the industry's broadest portfolio of injectable medicines, and we look forward to bringing this experience to producing high-quality biosimilars."

Fresenius Kabi's BLA submission for its pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data. The application includes the results of two pivotal clinical trials that showed equivalent pharmacokinetic and pharmacodynamic profiles to the originator Neulasta®, as well as similar immunogenicity in healthy volunteers. The safety of MSB11455 was also comparable to Neulasta^®.

Fresenius Kabi is participating as an Enhanced Exhibitor at ASCO20 Virtual, a meeting of the American Society of Clinical Oncology, which is taking place virtually May 29-31, 2020. #ASCO20 #biosimilars