Generic version of pharmaceutical is very popular now as its availability at low cost. When innovator drug product is going off patent pharmaceutical companies may file application (ANDA) for the approval of generic version. Generic versions are also available in biopharmaceutical products called biosimilars. European countries (EMA) have already established powerful guideline first. Then after WHO and USFDA came to regulate biosimilars. Recently India has released guideline for approval of biosimilars in August 2012. Basic concepts and principle are same but little difference in scope, reference product, and exclusivity and data requirements. This article will review all that guidelines for approval of biosimilars.
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