Adding to the flurry of recent biosimilar approvals, on March 7, Fresenius Kabi became the latest to receive an FDA nod. Their product, Tyenne, a tocilizumab biosimilar (reference product Actemra®), is the second drug in the category to receive approval.
Tyenne (tocilizumab-aazg) is approved to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and systemic juvenile idiopathic arthritis.
Tyenne was approved in both intravenous and subcutaneous formulations. “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,” stated Michael Schönhofen, President, Biopharma, Fresenius Kabi, in a press release. “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 first biosimilar tocilizumab (Tofidence™) was approved September 29, 2023, and has not been launched by Biogen.
As part of a patent settlement with Roche, maker of the reference product, Fresenius Kabi will launch at an undisclosed date, likely in 2025. The US revenues for Actemra were approximately $1.4 billion in 2023. Tyenne is already approved in the EU and is marketed in several countries. This approval marks the third FDA biosimilar approval for Fresenius Kabi, with other products being sold for pegfilgrastim (Stimufend®) and adalimumab (Idacio®).
