India To Become A Biosimilar Powerhouse

India is set to become a “biosimilar powerhouse”, with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts at Datamonitor.

“The domestic market for biosimilars in India is limited by low levels of health insurance and therefore poor access to biologic drugs; however given the high level of branded-generic loyalty of the emerging middle class, this could act as a driver of biosimilar uptake,” Alistair Sinclair, Healthcare Analyst at Datamonitor, said in a press statement.

Many copycat biologics are already available in India, but they are often approved as new drugs, which makes it difficult to quantify biosimilars sales. Despite this, Datamonitor estimates that biosimilars sales in India are between $20 million and $200 million, but will grow to approximately $580 million by 2012.

Many Indian biosimilar manufacturers are also looking to expand globally, but they could face difficulties in these areas. Although biosimilars are prevalent in India, their emergence in Europe and the US has been much slower. The EU began approving biosimilars in 2006 and a handful of products are now available, but the US only approved its first biosimilar in 2010. In both regions there are still a number of regulatory hurdles and concerns. Pharmaceutical Technology Europe discussed some of these issues in a special feature on biosimilars published last year.

“The developed pharma markets may be difficult to access alone due to the complex and expensive clinical trials and registration process,” said Sinclair. “However, licensing agreements with multinational companies, such as the recent deal between Biocon and Pfizer, can facilitate access to these markets.”

www.datamonitor.com