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A biosimilar is a biological medicine that is similar, but not identical, to an already registered reference biotherapeutic product in terms of quality, safety, and efficacy. These drugs may be also called as biosimilar products‘, follow-on protein products’ and subsequent-entry biologics‘. The United States enacted the Biologics Price Competition and Innovation Act (BPCI) in the end of March 2010 to providing an application pathway for follow-on biological products under sections 7001 to 7003 of the Patient Protection and Affordable Care Act and also codified in 42 USC 262(k). In Europe, in 2001, legislation concerning biosimilar was codified as Directive 2001/83/EC to create a new marketing authorization procedure for similar biological medicinal products and also Committee for Medicinal Products for Human Use (CHMP) of the EMA is concern with these biosimilar products. The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation and approval of biosimilar medicines developed by pharmaceutical companies for use in Japan and in March 2009, biosimilar guidelines published by the MHLW. In India, Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Approval Committee (GEAC) of Central Drugs Standard Control Organization (CDSCO) is responsible for the development and preclinical evaluation of recombinant biologics drugs. This article having precise, concise, and simple comparison of US, Europe, Japan, and India related to biosimilar drugs regulations and litigation.
Biosimilar, USFDA, Biogenerics, Regulation, Litigation