Open AccessREGULATORY GUIDELINES FOR APPROVAL OF BIOSIMILARS IN INDIA, EUROPE, BRAZIL AND CHINA: A COMPREHENSIVE OVERVIEW
Author(s) -
Meenakshi Kanwar Chauhan,
Shipra Malik
Publication year - 2016
Publication title -
international journal of pharmacy and pharmaceutical sciences/international journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2656-0097
pISSN - 0975-1491
DOI - 10.22159/ijpps.2016v8i10.11753
Subject(s) - biosimilar , comparability , guideline , medicine , biological drugs , agency (philosophy) , product (mathematics) , china , business , pharmacology , microbiology and biotechnology , geography , disease , biology , philosophy , geometry , mathematics , archaeology , epistemology , pathology , combinatorics
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference biological product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise. EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in 2010 in Brazil and 2012 in India. Recently China published its guideline for biosimilar approval in 2015. This article summarizes the regulatory requirements for approval of biosimilars in India, Europe, Brazil, and China. These countries require comparability exercise of a biosimilar with reference biological product for generating comparative analytical, non-clinical and clinical data (usually one or two phase 1 and phase 3 comparative studies). A case study of infliximab biosimilar approval in India, Brazil and Europe has also been included.