Epirus, Ranbaxy win India approval for arthritis drug copy

Mumbai: Epirus Biopharmaceuticals Inc said India's drug regulator has approved its copy of a top-selling arthritis treatment, paving the way for its launch in the country early next year. The company's Indian partner, Ranbaxy Laboratories Ltd, will sell a copycat version of Johnson & Johnson's and Merck & Co Inc's infliximab, an anti-inflammatory drug with annual sales of about $6 billion.

The market for copycat biotech drugs, known as biosimilars, is becoming more lucrative as patents expire on older, high-priced antibody drugs that rank among the pharmaceutical industry's biggest sellers. With changing regulations and a looming biotech patent cliff, the global market for biosimilars is forecast to rise to $24 billion in 2019 from about $1.2 billion last year, according to market research firm Frost & Sullivan.

Infliximab, sold under the brand name Remicade, is used to treat rheumatoid arthritis, Crohn's Disease, psoriasis and other inflammatory conditions. In India, it sells at about 70,000 rupees ($1,150) per month.

Like its main rivals, Amgen Inc's Enbrel and AbbVie Inc's Humira, the drug works by blocking a protein called tumor necrosis factor. Epirus, a Boston-based biopharmaceutical company that focuses on developing biosimilar drugs for sale, said it would launch the Remicade biosimilar in India under the name Infimab by the first quarter of 2015.

Chief Executive Amit Munshi, citing various estimates, said the Indian market for Remicade was worth $8 million to $10 million a year. He declined to say how much Infimab would cost or to estimate how many patients might use the drug. The drug will be made in Mumbai by India's Reliance Life Sciences, part of billionaire Anil Ambani's Reliance Group Holdings.

Remicade copycats are already being sold elsewhere. South Korean drugmaker Celltrion Inc won approval in July for its version in Japan and is hoping for U.S. approval in 2015. Epirus is also in talks with Ranbaxy, as well as other Indian and international companies, about expanding sales of its biosimilar drugs in other regions, Munshi told Reuters.

"Ranbaxy has, under their license, quite a few markets in southeast Asia and North Africa," he said. "We're also working with other partners in places like Latin America."

Ranbaxy is not the only Indian drugmaker to explore production of biosimilar drugs. Dr. Reddy's Laboratories Ltd, for example, is developing biosimilars with Germany's Merck KgaA. Biocon Ltd has a tie-up with Mylan Inc, while Lupin Ltd has entered a deal to sell a biosimilar version of Sanofi SA's blockbuster insulin,