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India unveils biosimilar guidelines

Lays out regulatory pathway for manufacturers to bring biosimilars to market

India staked a claim to the emerging market in biosimilar medicines at this year's BIO meeting in Boston, with the release of national guidelines on the development of 'similar biologics'.

The guidelines, which come into immediate effect, have been prepared by India's Central Drugs Standard Control Organization (CDSCO), as well as various government ministries.

At a press conference to introduce the guidelines, Dr Maharaj Kishan Bhan, Secretary of the India's Department of Biotechnology, said they "lay out a clear regulatory pathway for manufacturers of similar biologics".

The overall aim was to develop a framework for biosimilars that is tailored to the operating environment in India and will allow manufacturers to bring safe and effective products to market more quickly and improve access to affordable medicines.

The document covers the criteria for selection of biosimilar drug candidates; the requirements for preclinical and clinical studies; applicable regulations within India; and additional measures, including, a need to submit post-market surveillance data for four years after a new product is introduced.

In addition to laying out a framework for biosimilar development by domestic companies, the document is also designed to encourage overseas pharma companies to manufacture these products in India, said Bhan.

The guidelines should also help avoid situations emerging in which intellectual property right (IPR) disputes result in litigation, he added.

India is hoping to mirror its achievement in small-molecule medicines, namely becoming the leading global source of affordable generic drugs.

According to market research firm BCC, the biosimilars market was worth around $2.5bn last year, but is expected to increase to $3.6bn by 2016 and then enjoy near-exponential growth as the first-generation monoclonal antibody drugs lose patent protection.

India's drugmakers are already gearing up to exploit the opportunity. For example, earlier this month Dr Reddy's Laboratories forged an alliance with Merck KGaA division Merck Serono to co-develop a portfolio of biosimilar medicines, focusing mainly on monoclonal antibodies used to treat cancer.

27th June 2012

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