Updated on 19 June 2012
The new guidelines require demonstration of similarity between similar biologic and the reference innovator product, and consistency in production process. If differences are significant then more extensive evaluation will be required to prove similarity.
India's definition of similar biologic is: a biological product or drug produced by genetic engineering techniques and claimed to be "similar" in terms of quality, safety, efficacy to a reference innovator product, which has been granted a marketing authorization in India by a competent authority on the basis of a complete dossier, and with a history of safe use in India.
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