US FDA win for Biocon raises hopes for other Indian pharma companies

Kiran Mazumdar-Shaw’s Biocon Ltd recently surpassed a significant milestone, winning the first approval from the United States Food and Drug Administration (USFDA) for a biosimilar drug from India. The nod, for a biological substance used to treat certain types of breast and stomach cancer, is seen as a landmark decision by the biopharma industry.

“Extraordinary. It’s an absolute landmark because the biosimilar guidelines in the US have been so tough,” says Vijay Chandru, chairman and managing director of Strand Life Sciences. Chandru, a professor at Bengaluru’s Indian Institute of Science, is a pioneering entrepreneur in the Indian biotech research ecosystem, and has previously led the Indian biotech lobby, Association of Biotechnology Led Enterprises (Able).

The US guidelines are tough in part to protect patients from foreign drugs and local innovator companies, Chandru says. “It’s been a real challenge to get through the USFDA regulations on biosimilars,” he adds. Many in the Indian industry believe that biosimilars can do to the next generation of biotech-led companies what chemical generic drugs did to the pharma companies—make them large businesses.

Biocon’s win raises hopes for other Indian pharma companies—some already sell biosimilars in India, including Dr Reddy’s Laboratories, Torrent Pharmaceuticals, Shantha Biotechnics and Wockhardt. Biocon, too, sells various other biosimilar drugs in India.


Biocon collaborated with Dutch company Mylan NV to develop its biosimilar Trastuzumab, which is sold as Herceptin by the current intellectual property owners Roche Holding Ltd and Genentech Inc. The biosimilar, comparable in properties to the original biologic, will be sold as Ogivri by Mylan and Biocon. The breakthrough gives them a shot at a global market estimated to be worth about $6.9 billion and projected to reach nearly $10 billion by 2025.

“The USFDA’s approval for Trastuzumab is a crowning moment that puts us in an exclusive league of global biosimilar players. It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world,” Mazumdar-Shaw said in a Biocon press release. Sources say Biocon and Mylan may have invested as much as $150 million since entering a partnership in 2010 to develop their biosimilar.

Herceptin patents will expire in the US in 2019. Mylan and Biocon’s biosimilar for Herceptin is also under review by regulatory authorities in Australia, Canada, Europe and other markets. The company says the drug is approved in 19 countries, including India.