NEW DELHI (TIP): Drug maker Ranbaxy Laboratories has entered into a licensing agreement with Epirus Switzerland GmbH, the Swiss arm of Boston-based Epirus Biopharmaceuticals Inc, for introducing a biosimilar version (BOW015) of infliximab, a drug currently sold by Johnson & Johnson under brand Remicade for treatment of rheumatoid arthritis. According to the agreement, the Swiss firm will develop and supply the product, and upon regulatory approval, Ranbaxy will market the same in India and other emerging markets, the Indian drug maker said in a statement on Thursday. Currently, no biosimilar of Infliximab approved in India. Biosimilar is the generic version of a biotechnology-based product. According to experts, once Ranbaxy gets an approval and launches the product in India, the drug’s price is expected to come down significantly.

The medicine, available in the form of injection, is priced at Rs 82,000 for a single course, sources said. “We are pleased to partner with Epirus for biosimilar infliximab. We will utilise our strong frontend capabilities in making this product available in India and other parts of the world,” said Sanjeev I Dani, executive vice-president and head (global strategy) at Ranbaxy. While there have been some domestic companies such as Biocon dedicated towards biotechnology products, recently even pharmaceutical companies such as Cipla, Ranbaxy and Lupin have turned their attention towards the segment. Recently, Biocon secured approval in India for the first biosimilar version of Roche’s Herceptin, the world’s best-selling breast cancer drug.

The biotech company had also jointly developed the product with US-based generic drug maker Mylan Inc. Experts say some of the recent regulatory developments may have prompted the move. In mid- 2012, the Department of Biotechnology along with the Drugs Controller General of India framed the guidelines for biotech products to be developed and marketed in the country. The norms outline data requirements for pre-clinical and clinical trials and also talk about pre-marketing and post-marketing data. Before this, there was no separate set of guidelines for biosimilars in India, and such drugs were approved on the basis of general guidelines.

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Volume 10 Issue 41 | New York | Oct 21

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