The Indian biosimilars market has tripled in the last four years - from about $200-mn in 2008 to around $580-mn in 2012 - due to an enabling environment, according to Mr. Vijay Kurup, Vice President, Ernst & Young.Regulatory and market access environment in India is conducive to biosimilars, leading to launch of several biosimilar products, he said. For biosimilars, phase I/II trials are typically not required, and only phase III bridging studies are required for registration. Moreover acceptance of biosimilars is high in a price sensitive market and substitution with innovator drug is automatic, he informed.
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