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India's biosimilar regulations

New guidelines for “similar biologics” launched August 15 will help address local patient access to expensive drugs while serving to attract international manufacturers to India. The Department of Biotechnology and Central Drugs Standard Control Organisation developed the regulatory framework with input from industry and academia. Under the new guidelines, manufacturers must prove similarity to a reference biologic already approved in India or licensed and sold for at least four years in a regulated market. The biosimilar should be comparable to the innovator drug in safety, efficacy and quality as demonstrated by analytical and clinical trials and the preclinical and clinical studies should also be comparative in nature. Approval “without involved clinical trials” is possible if manufacturers prove close similarity to its reference product, and show consistency in production process. Anurag Rathorem at Indian Institute of Technology in New Delhi, who contributed to the guidance says, “We took both the US and European guidelines into consideration while drafting.” The guidelines have received a cautious welcome from industry. “The requirement for comparative clinical trials will certainly have an impact on the company's budget allocation,” says Geena Malhotra, chief of research at Mumbai-based Cipla. Recent deals between Mumbai-based Emcure Pharma and Basel-based Roche and between Merck Serono and Dr. Reddy's Laboratories in Hyderabad are a testament to India's growing attractiveness as a biosimilars manufacturing hub.


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Jayaraman, K. India's biosimilar regulations. Nat Biotechnol 30, 815 (2012).

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