FDA Accepts BLA for Biosimilar of Actemra

Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval in both intravenous and subcutaneous administration.

The FDA has accepted for Fresenius Kabi biologics license application (BLA) for a biosimilar of Genentech’s Actemra (tocilizumab), a monoclonal antibody that is used to treat patients with moderate-to-severe rheumatoid arthritis. Additionally, the FDA has issued an emergence use authorization for Actemra to treat patients who are hospitalized with COVID-19.

Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval for both intravenous and subcutaneous routes of administration.

The submission 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 Actemra patients to the biosimilar. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.

“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,” Dr. Michael Schönhofen, Fresenius Kabi chief operating officer, said in a press release.

Genentech’s Actemra is under review by the FDA for full approval for treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen. During the COVID-19 pandemic, Genentech struggled with supply shortages, but as of July 2022, the company announced it now has a stable supply.