India releases draft ‘similar biologic’ guidelines

Home/Guidelines | Posted 29/06/2012 post-comment0 Post your comment

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.

picture 121

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’ [1].

Related articles

India at the biotech crossroads

Biotech growth and biosimilar opportunities in India


1.  GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 29]. Available from:

Permission granted to reproduce for personal and educational use only. All other reproduction, copy, retransmission or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Biospectrum, India Education Diary

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010