FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim

May 27, 2020

Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim).

This BLA represents Fresenius Kabi’s first biosimilar candidate submitted to the FDA. Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals and Devices Division, said: “This is an important achievement in the development of our biosimilar pipeline in the US. We continue to expand our portfolio to deliver high-quality and affordable therapies, a vital need in the treatment of cancer and other life-threatening diseases.”

MSB11455 stimulates the growth of certain white blood cells which are essential to fight infections, a common event in patients with cancer receiving chemotherapy. MSB11455 was developed by Fresenius Kabi’s biosimilars team based in Switzerland. 

Fresenius Kabi’s BLA submission for the 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 profile to pegfilgrastim, as well as similar immunogenicity in healthy volunteers. The safety profile of MSB11455 was also comparable to pegfilgrastim.

Fresenius Kabi also received acceptance for review of its submission for Marketing Authorization Application for MSB11455, a pegfilgrastim biosimilar candidate, from the European Medicines Agency this month.

About MSB11455, a biosimilar candidate of pegfilgrastim

Pegfilgrastim is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or GCSF) which serves to stimulate the production of white blood cells (neutrophils). The reference product Neulasta®* is indicated in the US to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

* Neulasta® is a registered trademark of Amgen

For more information about Fresenius Kabi’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com.

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

Fresenius Kabi employs around 40,000 people worldwide. In 2019, the company reported sales of more than €6.9 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

For more information visit the company’s website at www.fresenius-kabi.com.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Mats Henriksson (Chairman), Marc Crouton, John Ducker, Dr. Oskar Haszonits,
Dr. Christian Hauer, Dr. Michael Schönhofen, Gerrit Steen
Chairman of the Supervisory Board: Stephan Sturm
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654