Fresenius Kabi’s Biosimilar for Actemra Gets FDA Approval

Fresenius Kabi

Pictured: Fresenius Kabi's office in Toronto iStock/JHVEPhoto

Another biosimilar approval from the FDA was handed down Thursday, as the regulator approved Fresenius Kabi’s Tyenne biosimilar for Genentech’s Acterma (tocilizumab).

According to Fresenius Kabi, Tyenne is the first biosimilar to Acterma which has both IV and subcutaneous formulations approved by the FDA. However, as part of a patent settlement with Genentech, the German pharma has a license to market its biosimilar products in the U.S., which will start on confidential license dates.

The biosimilar is now approved to treat inflammatory and immune diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis and systemic juvenile idiopathic arthritis.

“The FDA’s approval of our tocilizumab biosimilar is a breakthrough in bringing high-quality, affordable, and accessible autoimmune treatment options to patients and healthcare providers,” Michael Schönhofen, Fresenius Kabi president of biopharma, said in a statement. “We are expanding our biosimilars portfolio for immunology and oncology-related diseases, and we are committed to improving the quality of patients’ lives and lightening the burden on healthcare systems around the world.”

The Tyenne biosimilar has already been launched in 10 countries but Fresenius Kabi plans to launch it in additional  nations this year and in 2025. Acterma pulled in over CHF 1.2 billion ($1.39 billion) in sales in the U.S. in fiscal year 2023 and CHF 2.6 billion ($2.9 billion) in global sales.

“Tyenne met the rigorous FDA requirements for biosimilarity and is another treatment option for patients and their healthcare providers,” Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi Biopharma, said in a statement.

Tyenne is the third FDA-approved biosimilar for Fresenius Kabi as Stimufend, a Neulastat biosimilar, was approved in February 2023 and the Humira biosimilar Idacio was approved in July 2023.

The Tyenne approval comes as the FDA gave its approval to two of Sandoz’s biosimilars this week. The regulator approved Sandoz’s Jubbonti, which will go up against Amgen’s Prolia in treating osteoporotic men and postmenopausal women at risk of fracture. The other approved biosimilar is Wyost, similar to Amgen’s Xgeva, which is intended to prevent skeletal-related events in patients with multiple myeloma and solid tumors with bone metastases.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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