Fresenius Kabi announces Acceptance of its Marketing Authorization Application by the European Medicines Agency for MSB11456, a Tocilizumab Biosimilar Candidate
August 18, 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 its Marketing Authorization Application (MAA) for MSB11456, the company’s tocilizumab biosimilar candidate, has been accepted for review by the European Medicines Agency (EMA).
Fresenius Kabi’s MAA submission for its tocilizumab biosimilar candidate of RoActemra®* includes comprehensive analytical, non-clinical and clinical similarity data. The clinical development program was established to demonstrate similar pharmacokinetic, pharmacodynamic, efficacy, safety, tolerability, and immunogenicity to the reference product and includes also switch data from RoActemra® to MSB11456. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. These two presentations offer a comprehensive, alternative solution for patients treated with tocilizumab. This submission represents Fresenius Kabi's third biosimilar candidate submitted in the European Union.
“The EMA’s acceptance of the MAA for our proposed tocilizumab biosimilar candidate is a great testimonial of Fresenius Kabi’s long-term commitment to offer a compelling biosimilars portfolio for autoimmune diseases and cancer-related conditions to even more patients and healthcare providers around the world. We take responsibility to provide high-quality, affordable, and accessible treatment options while offering alternative solutions to ease the cost burden of healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi Chief Operating Officer and Member of the Fresenius Kabi Management Board. “In line with the company’s Vision 2026 we are expanding our biosimilars business to become a leading biopharmaceuticals partner worldwide.”
The proposed tocilizumab biosimilar candidate is expected to enlarge the company’s biosimilar portfolio for patients living with autoimmune diseases. The U.S. Food and Drug Administration (FDA) has recently accepted for review the company’s Biologics License Application (BLA) for its tocilizumab biosimilar candidate. Currently, the company’s adalimumab biosimilar Idacio® is commercialized in more than 30 countries worldwide and its pegfilgrastim biosimilar Stimufend® received marketing authorization from the European Commission (EC) earlier this year.
Fresenius Kabi is seeking the European Commission’s approval for its tocilizumab biosimilar in both intravenous and subcutaneous routes of administration and it expects to receive both the EC’s and FDA’s approval in 2023.
About MSB11456, a proposed biosimilar of Actemra®/ (tocilizumab)
MSB11456 is Fresenius Kabi’s biosimilar candidate of tocilizumab (reference product RoActemra®).
MSB11456 is being developed as a tocilizumab biosimilar by Fresenius Kabi using advanced analytical and manufacturing methods. Tocilizumab is used in the treatment of several immune-medicated conditions including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome and COVID-19. 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.
* Ro-Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
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