New guidelines for biosimilars in India
The release of guidelines for biosimilar drugs in India reportedly created a buzz at last month’s BIO meet at Boston. The 52-page document, titled, ‘Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India’ covers both biosimilars developed in India as well as those imported into the country.
There has been a fair amount of interest in these guidelines, both from Indian biopharma companies as well as global players. In fact, an industry observer at the BIO meet tweeted that officials associated with DBT projected these guidelines “as the start of a major regulatory reform process in 2012.”
When it comes to regulating biosimilars, the European Medical Agency (EMA) has been the clear leader, releasing guidelines for the licensing of biosimilars way back in 2005. Other regulators, including countries in Asia such as South Korea, Malaysia, Taiwan, and Sri Lanka have since referenced these guidelines while preparing their own, with the first three countries choosing to tweak them to meet their local scenarios, without, of course, compromising patient safety or product quality.
In the interests of harmonising biosimilar regulations across the world, the WHO also released biosimilar guidelines in 2009 that could be adopted by national regulatory agencies worldwide as a base to formulating their own guidelines. The US released its Biologics Price Competition and Innovation Act of 2009 in 2010 as well.
The Indian biosimilar guidelines follow what is now more or less the accepted practice of requiring a biosimilar to prove similarity to an approved reference biotherapeutic product. Again following the EMA’s experience, Indian regulatory authorities held many consultations with industry representatives during the draft stages. Thus while it is early days as yet, one expects that the guidelines will be generally well accepted by Indian biopharma companies, who have long felt that having such rules in place would benefit not just the patient but also ultimately lead to a better image of Indian biosimilars in the global market.
Global players will have the usual concerns. For instance, in February this year, a letter from BIO hoped that the guidelines would preserve the “incentives to research, develop and manufacture new and innovative therapies and cures, as well as new indications.” It had also advised that non-patent data exclusivity needs to be awarded to the original innovator so that biosimilar companies cannot rely on any health authority’s prior approval of the innovator’s reference biologic product.
What is a fair period of data exclusivity? How well has India’s biosimilar guidelines addressed these issues? Is there a balance between the interests of the various stakeholders involved? Do write in with your comments on India’s biosimilar guidelines and we’ll be sure to feature it along with a detailed analysis from industry experts.
Viveka Roychowdhury
Editor
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