India: India's Biosimilar Guidance to Come Into Effect in August

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By Louise Zornoza, RegLink

India’s Central Drugs Standard Control Organization (CDSCO) published the final biosimilar guidance setting forth the regulatory requirements for marketing authorization for such products on 4 July 2012.

The guidance covers “similar biologics that contain well-characterized proteins” and permits the use of a reference product not authorized in India, as long as the product has been approved and marketed for at least four years. A post-marketing Risk Management Plan is required because “similar biologics are authorized based on a reduced preclinical and clinical data package.”  

The guidance goes into effect on August 15, 2012.

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CDSCO - Guidelines on Similar Biologics: Regulatory Requirements for marketing Authorization in India

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