India and China set to dominate biosimilars market

While the US is still be ironing out its rules governing biosimilars, the Indian market is witnessing nearly 20% annual growth in the segment. Low cost manufacturing, less expenditure incurred on research and development and a higher number of drug applications and approvals mean that together India and China could command around 70% of the US$20bn global biosimilars market. Shorter time to market and increasing demand for low cost products could see the annual growth rate for biosimilars reach 30% during 2014-18. It is estimated that patents worth $80bn for biopharmaceuticals are expected to expire globally in 2015.

Biosimilars have emerged as a lucrative market for Gujarat's pharmaceutical companies. Leading companies like Cadila Healthcare, Intas Pharmaceuticals and Torrent Pharmaceuticals have begun tapping the biosimilars market with their product pipelines. Sales margins on biosimilar drugs range from 20% to 80%, according to analysts. On the other hand, almost 90% to 95% of the innovator price of a drug is eroded when a generic version of a small molecule drug is launched.

Cadila Healthcare has become the first company to launch the biosimilar of Adalimumab, the preferred therapy for the treatment of auto immune disorders like rheumatoid arthritis and psoriasis. According to sources, a vial of the original version costs about $1,000 in the US, while Cadila is likely to sell the same for $200. 'The biosimilars segment is the future and the competition is also low at present. Last year, we launched around seven products and about four more are in the pipeline,' said Pankaj Patel, Chairman and Managing Director, Cadila Healthcare.

Similarly , Intas recently launched Intacept, the biosimilar to Amgen's Enbrel. Binish Chudgar, vice chairman of Intas Pharma said that the company now has nine biosimilar products in the market.

According to the Pharmaceuticals Export Promotion Council (Pharmexcil), more than 100 major Indian pharmaceutical companies are in the process of investing in research on biosimilars. Another leading pharma company from Ahmedabad, Torrent Pharmaceuticals, has entered into an exclusive licensing agreement with Reliance Life Sciences for marketing three biosimilars - rituximab, adalimumab and cetuximab - in India. Reliance Life Sciences will develop these products at its plant in Mumbai and supply these products to Torrent Pharma.

Late last year, Cadila had announced the launch of a copycat version of AbbVie’s blockbuster biologic Humira, which targets autoimmune disorders such as rheumatoid arthritis. The product is touted as world’s top selling drug. The biosimilar, named Exemptia, would be marketed as a 40mg injection administered once every alternate week and launched at one fifth of Humira’s price of approximately $1,000 per injection.

Biocon’s CANMab, a breast cancer therapy that is a generic of Roche’s Herceptin, was launched in February 2014 with a 25% discount to the innovator price.