Reforms set to propel biosimilar development in India

A slew of regulatory reforms is in the offing for the biotech industry in India, with the government seeking to accelerate biologics and biosimilar development in the country. Apart from an amendment to Guidelines on Similar Biologics, the industry is to get the benefit of certain measures that will facilitate commercial stockpiling of biosimilar products before issuance of marketing authorization in order to propel their launch in the market in line with the US Food and Drug Administration, reports The Pharma Letter’s India correspondent.

Several global policies across the pharma fraternity are changing and impacting businesses, said Ranjan Pai, chairman of Manipal Medical Group. The recent policy changes like the Generic Drug User Fee Act is expected to positively impact generic manufacturers in India, providing an increased return on investment and encouraging compliance with US regulation.

The pace of pharmaceutical innovation is set to accelerate in the country with biologics, he added. India is one of the leading manufacturers of similar biologics, and there is a thriving domestic market with 93 total products approved through 2019.