Fresenius Kabi’s Tocilizumab Biosimilar Candidate MSB11456 Receives Positive CHMP Opinion
Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the EMA CHMP has adopted a positive opinion recommending the granting of a marketing authorization for its tocilizumab biosimilar candidate MSB11456 referencing RoActemra®* (tocilizumab). MSB11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome, as well as for COVID-19.
The positive opinion covers both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations which offer a comprehensive, alternative treatment solution for patients treated with tocilizumab.
Pierluigi Antonelli, CEO Fresenius Kabi: “Our organization is fully committed to improving the quality of life of critically and chronically ill patients. In line with our Vision 2026 strategy, Fresenius Kabi is consistently broadening its biopharma portfolio to offer essential treatment options globally. Offering comprehensive, accessible, and high-quality therapies for patients is at the heart of our company. The recommendation for granting marketing authorization for our tocilizumab biosimilar candidate in the EU is a major milestone on our pathway towards leadership in the biosimilar sector. Our tocilizumab candidate will make a difference for patients with autoimmune diseases and will benefit health systems in the EU.”
“We are very proud to be at the forefront of providing an alternative, affordable, and high-quality tocilizumab treatment option to patients living with autoimmune diseases. With our expanding biosimilars portfolio for immunology and oncology related conditions, we will deliver on our promise to provide access to biosimilars to more patients and healthcare providers around the world. Our Vision 2026 growth commitment to biopharma and improving the quality of patients’ lives establishes us as a trustworthy partner to alleviate the burden on healthcare systems globally,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.
Once approved, MSB11456 would be the company’s third biosimilar granted marketing authorization by the European Commission, which will be valid in all member countries of the European Union. Next to its two commercially available biosimilars, Idacio®** (adalimumab) and Stimufend®*** (pegfilgrastrim), Fresenius Kabi has a growing pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.
About MSB11456, a proposed biosimilar of RoActemra® (tocilizumab)
MSB11456 (tocilizumab-aazg), is being developed as a biosimilar to the reference medicinal product RoActemra®, a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. Tocilizumab is a biological therapy approved in the European Union (EU) for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) as well as for the treatment of COVID-19.
MSB11456 demonstrates Fresenius Kabi’s commitment to providing access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for healthcare systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, will be available to patients and healthcare providers from launch in the EU.
* RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
** Idacio® (adalimumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries and is already commercialized in 38 countries worldwide
*** Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
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 for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more.
With its corporate mission of "caring for life", Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
Fresenius Kabi employs more than 42,000 people worldwide. In 2022, the company reported sales of more than €7.8 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: Pierluigi Antonelli (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654