Reach Us 44-7452-259145


A Comparision of US, Europe, Japan and India Biosimilar Regulations

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.

Author(s): Rajput Bane Singh

Abstract | Full-Text | PDF

Share this  Facebook  Twitter  LinkedIn  Google+
30+ Million Readerbase
Recommended Conferences
Google scholar citation report
Citations : 7472

International Journal of Drug Development and Research received 7472 citations as per google scholar report

International Journal of Drug Development and Research peer review process verified at publons
Abstracted/Indexed in
  • Google Scholar
  • Genamics JournalSeek
  • China National Knowledge Infrastructure (CNKI)
  • CiteFactor
  • Scimago
  • Directory of Research Journal Indexing (DRJI)
  • WorldCat
  • Publons
  • MIAR
  • ResearchGate
  • University Grants Commission
  • Secret Search Engine Labs
  • Euro Pub

View More »

Flyer image


tempobet giriş

tempobet giriş

tipobet süpertotobet yeni adres süperbahis 747 güvenilir bahis siteleri telefonda sex sohbet

rolex replica