Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA

May 22, 2020 I Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announced today that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim).

This submission is another milestone for Fresenius Kabi following last year’s approval and launch of the company’s adalimumab biosimilar in Europe. 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 entire biosimilar pipeline and oncology portfolio. 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 is a molecule that 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 MAA submission for 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.

About MSB11455, a biosimilar candidate of pegfilgrastim

Pegfilgrastim is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or GCSF) which stimulates the production of white blood cells (neutrophils). The reference product Neulasta®* is approved in the EU for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

* 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.

SOURCE: Fresenius Kabi

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