Fresenius Kabi’s Biologic License Application for Biosimilar Candidate Tocilizumab Accepted for Review in the U.S.

August 1, 2022

Fresenius Kabi, a global healthcare company that specializes in pharmaceuticals, medical technologies and clinical nutrition products for critical and chronic conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s 351(k) Biologics License Application (BLA) for MSB11456, the company’s biosimilar candidate for Actemra®*(tocilizumab).

Fresenius Kabi’s BLA submission for its tocilizumab biosimilar candidate includes analytical similarity and comprehensive clinical data. These are used to demonstrate similar pharmacokinetic, efficacy, safety, tolerability, and immunogenicity to the reference product, with and without switch from tocilizumab patients to MSB11456. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations designed to provide a comprehensive offering for patients treated with tocilizumab.

“The FDA’s acceptance of the BLA for our proposed tocilizumab biosimilar candidate is an important step forward in bringing a wider range of affordable and accessible autoimmune treatment options to patients and healthcare providers while reducing the cost burden to healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi Chief Operating Officer and Member of the Fresenius Kabi Management Board. “We are rapidly expanding and investing in our biosimilars portfolio for autoimmune and cancer-related conditions, including R&D and manufacturing, to be a reliable biosimilars partner in the U.S. and worldwide.”

“We are committed to developing high-quality, effective and safe biosimilars in our innovative Research & Development centers and today’s announcement confirms our focus to develop accessible treatment options for a wider patient group globally,” said Barbara Valenta-Singer, Senior Vice President & Chief Medical Officer Fresenius Kabi Swiss Biosim.

Following its Vision 2026, broadening in biopharmaceuticals is one growth vector for Fresenius Kabi. With the recently acquired majority stake at mAbxience* Fresenius Kabi’s footprint in biopharmaceuticals will be significantly strengthened by its extended biosimilars portfolio and by gaining access to the distinctive manufacturing capabilities of mAbxience. It will also allow Fresenius Kabi to provide end-to-end integrated biopharmaceutical solutions for customers from its state-of-the-art facilities.

Fresenius Kabi continues to expand its biosimilar portfolio in the areas of autoimmune diseases and oncology. The proposed tocilizumab biosimilar candidate is expected to enlarge the company’s biosimilar autoimmune portfolio for patients living with autoimmune diseases. Currently, the company’s adalimumab biosimilar Idacio® is commercialized in more than 34 countries worldwide and is expected to receive FDA approval in the U.S.

In the U.S., Fresenius Kabi is one of the largest providers of injectable medicines. The tocilizumab biosimilar candidate is the company’s third BLA submission to the FDA, after submissions for its pegfilgrastim and adalimumab biosimilar candidates. Fresenius Kabi expects to receive the FDA’s approval in 2023 and is seeking approval for its tocilizumab biosimilar in both intravenous and subcutaneous routes of administration. 

* subject to regulatory approvals and other customary closing conditions

About MSB11456, a proposed biosimilar of Actemra®/ (tocilizumab)

MSB11456 is Fresenius Kabi’s biosimilar candidate of tocilizumab (reference product Actemra®).

MSB11456 is being developed as a biosimilar of tocilizumab by Fresenius Kabi using advanced analytical and manufacturing methods for use in the treatment of several immune-medicated conditions including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. MSB11456 demonstrates our commitment to provide access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for healthcare systems.

* Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

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Fresenius Kabi is a global health care 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.

With its corporate mission of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi employs around 41,400 people worldwide. In 2021, the company reported sales of around €7.2 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

For more information, please visit www.fresenius-kabi.com

For more information about Fresenius Kabi’s biosimilars, please visit https://biosimilars.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: Michael Sen (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen
Chairman of the Supervisory Board: Stephan Sturm
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654