India has released regulatory guidelines outlining a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four years.
The release of the guidelines was announced at the BIO industry conference in Boston, USA, on 19 June 2012. Developed by India’s Department of Biotechnology and the Central Drugs Standard Control Organization, the guidelines provide requirements for pre-clinical evaluation of biological products that claim to be similar to already approved biopharmaceutical products, referred to by the Indian authorities as ‘similar biologics’. Therefore, the regulators will partly rely on data from the already approved products to ensuring safety, purity, potency and effectiveness.
Government spokesperson Dr Maharaj K Bhan from the Department of Biotechnology said, ‘it was a path-breaking development to bring clarity on the subject and lay out a clear regulatory pathway for manufacturers of similar biologics’. He added that ‘this will be good news for governments and patients alike as it will lead to significant reductions in costs with the introduction of a ‘similar biologic’ or biosimilar to the market.’
The Department of Biotechnology started working on the guidance two years ago, and despite assurances given at the BIO conference, the guidelines are still not available on the websites of the Department of Biotechnology and the Central Drugs Standard Control Organization.
Despite the lack of specific guidelines, India has shown a high acceptance of ‘similar biologics’. There are more than 50 biopharmaceutical products approved for marketing in India, more than half of which are ‘similar biologics’.
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