Pharma Trends

Biosimilars: The next growth opportunity

July 30, 2013: Biosimilars have emerged as the next growth opportunity for Indian pharmaceutical companies. Biosimilars are the ‘generic version of biopharmaceutical medicines’. It is the equivalent of a generic version of an off-patented biopharmaceutical drug. The global market for biosimilars is around $ 30 billion and is seen to grow at an compound annual growth rate of more than 50 per cent during 2010-15. Patent expiries of biologics, increasing healthcare costs, rising aging population, rising incidence of diseases such as cancer, diabetes and rheumatoid arthritis are the key drivers behind the growth of this market.

Indian drug companies recognising the opportunity in the biosimilar market have outlined their plans including identifying products and allocating funds to develop a robust product pipeline. Biosimilars from Dr Reddy’s including filgrastim, peg-filgrastim, rituximab, darbepeotin alfa have commercial presence in 13 emerging countries. Biocon, one of the leading biotechnology players is building a state of the art facility in Malaysia to supply insulin to the global market.

Cipla has acquired manufacturing facilities in India and China to develop biosimilars and has diverted more funds in China towards biosimilars. Wockhardt is one of the early entrants in the segment and has developed insulin and analogues. Lupin has ten proteins at different stages of development and plans to launch two biosimilar drugs for oncology in the country by the end of this year.

The government has been active in promoting this segment as well. The Department of Biotechnology along with the drug regulator has drafted guidelines for biosimilar drugs. Specific requirements for pre marketing and post marketing data and guidelines for pre-clinical and clinical trials for biosimilars are some of the proposed norms. The objective is to upgrade and maintain the quality of biosimilar products manufactured in India.

Experts point out that though biosimilars provide higher margins and higher revenue streams for companies, achieving regulatory and market success requires strict diligence and very strong technical skills. Companies would need to make huge investments and have dedicated manufacturing facilities and technical expertise to make a mark in this market.

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