Opdivo, Keytruda launches in India slated by end of 2016

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Bristol-Myers Squibb's ($BMS) Opdivo and Merck's ($MRK) Keytruda could see launches in India by the end of 2016, setting up competition in a major out-of-pocket market in Asia after sales of both therapies have focused on reimbursement in Japan, Australia and New Zealand.

The Economic Times, citing health ministry sources, said Keytruda (pembrolizumab) won a nod from the Drug Controller General of India, while Opdivo (nivolumab) has a clinical trials waiver from earlier this year with indications in melanoma and NSCLC.

The regulatory clearances, according to industry sources cited by the newspaper, set up marketing authorization approvals likely in 2016.

Both drugs have been in focus in Japan on sales competition and reimbursement pricing by Japan's Central Social Insurance Medical Council--known as Chuikyo.

In the case of Opdivo price restrictions may come into play this month. Opdivo is sold in Japan through Ono Pharmaceuticals, which holds rights as it has a previous deal with the originator company bought by BMS, Medarex.

In Australia and New Zealand, price concerns have been raised by reimbursement agencies in countries with high rates of melanoma. Singapore also approved sales earlier this year. But China has not approved either therapy.

National reimbursement for essential drugs limited in India and cutting-edge therapies often come into the market via generic makers.

That raises the prospect of compulsory license applications locally such as Bayer's Nexavar (sorafenib) by Hyderabad-based Natco Pharmaceuticals.

Other pathways to cheaper costs include the manufacturing and sales licenses awarded to Indian firms by Gilead Sciences ($GILD) for hepatitis C therapies in about 100 developing markets.

Figures cited by the newspaper said Keytruda has $566 million in global sales in 2015 while Opdivo boasted $942 million, placing them on the road to blockbuster status.

But last week BMS reported that Opdivo failed to meet clinical trial targets for first-line NSCLC therapy, giving Merck a potential leg up in the indication.

- here's the story from The Economic Times

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