There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application .
India announced the release of draft regulatory guidelines for ‘similar biologics’ at the BIO industry conference in Boston, USA, on 19 June 2012, and implemented them from 15 September 2012. The guidelines outline 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 .
Biosimilars are firmly established in the EU as copy biologicals with a clear and effective route for approval . It should be noted, however, that ‘similar biologics’ approved and marketed in India have not been subjected to the same rigorous controls and have not necessarily been compared in direct clinical trials to the reference product as is demanded in Europe by the European Medicines Agency. They should not therefore be referred to as biosimilars according to the definition proposed by EMA:
‘A biosimilar is a copy version of an already authorized biological medicinal product with demonstrated similarity in physicochemical characteristics, efficacy and safety, based on a comprehensive comparability exercise’ .
The Central Drugs Standard Control Organization is responsible for the approval, i.e. marketing authorisation of medicinal products, including these so-called ‘similar biologics’, in India.
India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. According to our research at GaBI Online, the first ‘similar biologic’ was approved and marketed in India for a hepatitis B vaccine in 2000. In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being ‘similar biologics’ , see Table 1.
Competing interests: None.
Provenance and peer review: Article prepared based on extensive research; internally peer reviewed.
Michelle Derbyshire, PhD, GaBI Online Editor
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