Organon acquired regulatory and commercial rights in the United States for TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion from Biogen. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
“Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s CEO. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”
The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions.
Large growth market
The biosimilars market is forecasted to grow from $29.4 billion in 2023 to $66.9 billion by 2028, driven by a CAGR of 17.8%, according to a report by MarketsandMarkets. The market, focusing on drug classes such as monoclonal antibodies, insulin, erythropoietin (EPO), and anticoagulants, is poised for substantial growth driven by increasing demand for cost-effective treatments amid rising chronic disease rates and the patent expirations of major biologics, noted the report. A key trend cited includes the rapid approval and adoption of biosimilars, particularly in oncology.
Challenges include complex manufacturing processes and regulatory obstacles, which are countered by opportunities in less regulated markets like Asia Pacific, noted the report, which cites players such as Novartis, Pfizer, and Amgen as pivotal in shaping industry dynamics through innovation and strategic expansions.
