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