Fresenius Kabi’s Biologics License Application for Biosimilar Candidate Tocilizumab Accepted for Review by the FDA

“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 SwissBiosim.

Following its Vision 2026, broadening in biopharmaceuticals is one growth vector for Fresenius Kabi. With the 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.