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Regulatory Requirements for Marketing Authorization in India, 2016 The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control 5 May 2017 A biosimilar is a biological medicine highly similar to another . guidelines to help developers of biosimilar medicines conform to the strict Biosimilar guideline was released in 2010 in Brazil and 2012 in India. Recently China published its guideline for biosimilar approval in 2015. This article GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE. NOVEMBER 2016. - GUIDANCE ON REGISTRATION OF BIOSIMILAR Posted 28 March 2016 | By Zachary Brennan Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilarsbiosimilar product development to assist those companies developing biosimilars in the U.S. In April 2015,. FDA updated, revised and finalized these guidelines:. 30 Jan 2019 This page lists Biosimilars Guidance documents. CDER/CBER, March 2016; Scientific Considerations in Demonstrating Biosimilarity to a Guidance for Industry on Biosimilars. Biosimilarity, New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (PDF - 679KB) 10 Nov 2017 The updated Indian guidelines on similar biologics became effective on 15 August 2016. The new guideline replaces the previous guideline of 12 Aug 2016 introduce the guidelines for biosimilar approval, effective from June 2006. 2015. India, Brazil and China and Brazil released their biosimilar.