A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India

  • Anshul Bansal
  • Vikesh Kumar Shukla
  • Shikha Chauhan


The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing approval for Biosimilar products. Biological medicines are biotechnology developed drugs having large molecule which is complex in nature and are very sensitive to manufacturing conditions and parameters. Even a minor change in manufacturing conditions alters the quality and safety aspects of end product owing to increased risk for immune response. Biopharmaceutical companies use information technology such as molecular modelling and statistical data for drug development. Biosimilar drugs have moderate marketing cost which is alluring and generally 40 to 50 % less to that of originator drug product. Biosimilars are also known as “follow on biologics” or “similar biologics”. The following points needs consideration such as global harmonization, extrapolation studies, interchangeability study, long term post marketing studies to gain physician confidence in biosimilars.

Keywords: Biopharmaceuticals, Biosimilars, United states Food and Drug Administration, Biologics Licence Application (BLA), European Medical Agency (EMA)


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How to Cite
Bansal, A., V. K. Shukla, and S. Chauhan. “A Comprehensive Study of Regulatory Compliance for Biosimilars in US, EU and India”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 2, June 2019, pp. 17-34, doi:10.22270/ijdra.v7i2.313.

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