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Comparative Studies | Pharmaceutical Science | India | Volume 12 Issue 8, August 2023
Current Status: Regulatory Oversight of Biosimilars in India, United States of America and Europe
Shubham [76] | Dr. Rajiv Girdhar [4]
Abstract: Background: A similar biologic product, also known as a biosimilar or follow - on biologic, is very similar to the reference product in terms of quality, safety, and efficacy. These pharmaceuticals are used both as primary treatments and as stand - ins for primary treatments for numerous chronic conditions. Each country has created its own rules for development and approval, and some nations are embracing WHO recommendations. The relevant bodies engaged in the approval procedure in India include the Institutional Bio - Safety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC), and CDSCO. The legal basis of Directive 2001/83/EC's Article 10 (4) in the EU specifies the criteria for Marketing Authorization Applications (MAAs) based on the proof of the similarity between the two biological medical products. Biotech products may be licenced under the US Biologics Price Competition and Innovation Act of 2009 (BPCIA). This article provides a table - formatted review of the regulatory frameworks in India, the USA, and the EU. Objectives: The objective of this topic is to compare the regulatory oversight of biosimilars in India, USA, and Europe. This comparison intends to highlight significant parallels and discrepancies between each region's approval procedures and post - marketing surveillance policies and regulations for biosimilars. Conclusion: In comparison to India and the USA, Europe leads in the development of biosimilars, with distinctions in definitions, guidelines, reference product selection, and data requirements. Although there are similarities, regulatory standards must be unified for global clearance of biosimilars.
Keywords: Biosimilar, CDSCO, US FDA, EMA, Litigation, Regulation, Comparability
Edition: Volume 12 Issue 8, August 2023,
Pages: 1141 - 1146