BLA Accepted for Fresenius Kabi Tocilizumab Biosimilar

FDA has accepted the biologics license application (BLA) for Fresenius Kabi’s biosimilar candidate for tocilizumab, the company announced earlier this week.

The candidate, MSB11456, would reference Actemra, an immunosuppressive drug used to treat autoimmune conditions that include moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

According to a statement from the company, the BLA submission includes analytical similarity and comprehensive clinical data needed to demonstrate similar pharmacokinetic, efficacy, safety, tolerability, and immunogenicity to the reference product, with and without switch from tocilizumab to MSB11456. The application features presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. In its statement, the company said it anticipates FDA approval in 2023.

“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 health care providers while reducing the cost burden to health care systems,” Michael Schönhofen, PhD, Fresenius Kabi chief operating officer and management board member, said in the statement. “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 United States and worldwide.”

Fresenius Kabi recently acquired a majority stake at mAbxience, which strengthened its biosimilars portfolio and offered access to new manufacturing capabilities. The proposed tocilizumab biosimilar candidate would complement other products in a portfolio that includes the company’s adalimumab biosimilar, Idacio, which is commercialized in more than 34 countries and is under FDA review.