Indian Pharma Set to Benefit from New US Biosimilar Rules

The US Food and Drug Administration's (FDA) draft guidance aimed at speeding up and making less expensive biosimilar development is going to be a massive relief to Indian pharma and biotech companies.

This move is a part of an overall strategy to lower the prices of drugs for Americans and to facilitate quicker access to less expensive biologic therapies.

The agency also wants to do away with most efficacy clinical trials and, instead, allow developers to demonstrate equivalence with reference biologics through advanced analytical and functional testing.

Industry insiders believe that such a transition can reduce the time of the development process from five to seven years to as little as two.

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Biocon, Dr. Reddy’s Laboratories, Intas, and Cipla, the companies which have loaded themselves with biosimilar research, are going to be the ones who will make the most of this simplified regulatory pathway. Shreehas Tambe, Managing Director of Biocon Biologics, said, "This progressive step will help to biologics get to the market faster at a lower cost."

Umang Vohra, Cipla’s MD, referred to the move as "a big positive for the industry," and emphasized the possible savings of $40–90 million per product.

The policy, as per Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, will permeate patient access to low-cost drugs and also India will strengthen its position as a global leader in biosimilars. With a large number of biologics scheduled to go off-patent over the next ten years, Indian companies will be the ones to exploit the $100-billion US biologics market the most.