Nichi-Iko and Sanofi join forces for biosimilar infliximab in Japan
This article was originally published in Scrip
The large and growing Japanese market for Mitsubishi Tanabe Pharma's (MTP) Remicade (infliximab; licensed from Johnson & Johnson) is continuing to attract biosimilar developers, with Nichi-Iko becoming the latest firm to reveal plans.
The TNF-alpha-targeting antibody is approved in several indications in the country but used mainly in rheumatoid arthritis, and MTP is forecasting total sales of ¥66.4 billion ($862 million) for the product this fiscal year. Other companies to have disclosed that they are starting work on biosimilar versions include Nippon Kayaku, which is developing a product under an alliance with the South Korean firm Celltrion.
Nichi-Iko, which has its main business in conventional small molecule generics, said it would progress biosimilar infliximab under its existing 49%-owned Japanese joint venture with Sanofi. Set up in 2010, this is developing small molecules and follow-on biologics and also distributing some older Sanofi products, spearheading the French group's entry into the Japanese generics sector (scripintelligence.com, 1 June 2010).
Nichi-Iko told Scrip that its plans for biosimilar infliximab extend only to Japan at present. However, it could not provide a clear date for the likely expiry of exclusivity for the original product in this market, given what it noted was a complex intellectual property situation.
The firm acquired a one-third holding in another South Korean firm, Aprogen, in 2010, in an alliance that will exclusively develop in Japan several Aprogen follow-on biologics, including trastuzumab (Roche's Herceptin) and rituximab (Roche/Biogen Idec's Rituxan/MabThera) in addition to infliximab.
The market for biologic therapies for rheumatoid arthritis in Japan, where several anti-TNF drugs have been commercialised, has been estimated at around ¥140 billion. MTP launched the once-monthly subcutaneously injected antibody Simponi (golimumab; also licensed from Johnson & Johnson) for the indication last September.