Development Name 'CT-P47' FDA Application Completed
Prepared for Both Intravenous and Subcutaneous Injection... Overcoming Patent Barriers
Celltrion has announced its entry into the global biosimilar market for the autoimmune disease treatment drug Actemra (generic name: tocilizumab), valued at approximately 4 trillion KRW.
On the 29th, Celltrion revealed that it has completed the U.S. Food and Drug Administration (FDA) approval application for 'CT-P47,' a biosimilar developed for Actemra. Actemra, developed by the Swiss multinational pharmaceutical company Roche, is a drug that inhibits interleukin (IL)-6, a protein that causes inflammation in the body. In 2022, it formed a massive global market with sales approaching $2.9 billion (about 3.8 trillion KRW).
Although the main patents for Actemra expired starting in the U.S. in 2015, some patents remain valid, so the biosimilar market is expected to open in earnest in the second half of this year. In addition to Celltrion, U.S. company Biogen and Germany’s Fresenius Kabi have also joined the development competition. In the U.S., where Celltrion has applied for approval, Biogen’s 'Topfidans' (development code BIIB800) took the lead as the first mover. It received FDA approval in September last year and has already started sales in China and Hong Kong. In Europe, Fresenius Kabi has also received approval for 'Tienee.' Celltrion plans to submit approval applications to major countries such as Europe and Canada following the U.S. CT-P47 is the development code, and the product name has not yet been disclosed.
An important competitive factor for Actemra biosimilars is securing convenient administration formulations. Actemra is sold not only as an intravenous injection but also in a subcutaneous injection form, which offers greater convenience. Celltrion plans to release both formulations to the market. However, the patent for Actemra’s subcutaneous injection expires only in 2031. Roche filed a patent dispute against Celltrion, but Celltrion succeeded in invalidating Roche’s patent by receiving a patent invalidation decision from the U.S. Patent Trial and Appeal Board in October last year. Meanwhile, Biogen resolved its obstacle by reaching a patent dispute settlement with Roche in the same month and is rushing to officially launch the product.
Celltrion previously confirmed the equivalence of CT-P47 through a Phase 3 clinical trial involving 471 rheumatoid arthritis patients. The difference in the change of disease activity from baseline between the original treatment group and the CT-P47 treatment group met the equivalence criteria. Furthermore, the experimental group that switched between Actemra and CT-P47 showed similar results in efficacy, pharmacokinetics, and safety. Celltrion applied to the FDA for indications including rheumatoid arthritis, COVID-19, giant cell arteritis, and juvenile idiopathic arthritis. Actemra is also used as a treatment for severe COVID-19 patients in the U.S. and South Korea.
A Celltrion official stated, “Based on the results confirmed through global Phase 3 clinical trials, we have applied for product approval in the U.S., the world’s largest market. Going forward, we will expand our autoimmune disease portfolio with interleukin inhibitors following tumor necrosis factor (TNF)-alpha inhibitors such as 'Remsima' and 'Yuflyma,' and increase our market share in the global market.”
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
