Regulatory Perspective of Biosimilars In India

Authors

  • Sirisha Katla Pharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics J.S.S College of Pharmacy, S.S Nagar, Mysore-570015, India.
  • T. M. Pramod Kumar Pharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics J.S.S College of Pharmacy, S.S Nagar, Mysore-570015, India.
  • V. Yugender Reddy Pharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics J.S.S College of Pharmacy, S.S Nagar, Mysore-570015, India.
  • Akhilesh. P Pharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics J.S.S College of Pharmacy, S.S Nagar, Mysore-570015, India.

Keywords:

Biosimilars, patent, CDSCO, Biopharmaceutical companies, RCGM

Abstract

Biosimilar drugs are follow-on versions of original biopharmaceutical medicines. They are independently developed after the patent protecting the original product has expired. Biosimilars are designed to target specific components of immune system as these drugs are capable of targeting proteins in a more specific fashion, yet have lower risks of systemic sideeffects; they have considerable advantages over the older Immunomodulators. As these products are more effective Indian bio-Pharma companies carry the advantages of low cost manufacturing and a highly skilled workforce with global expertise. Biosimilar medicines are intended to have the same mechanism of action for the same diseases as the original biopharmaceutical drug. The regulatory pathway for biosimilars in India was developed jointly by Central drug standard control organisation (CDSCO) & Department of Biotechnology (DBT) through Review Committee on Genetic Manipulation (RCGM).

Downloads

Download data is not yet available.

Published

2017-01-01

How to Cite

Katla, S., Kumar, T. M. P., Reddy, V. Y., & P, A. (2017). Regulatory Perspective of Biosimilars In India. Asian Journal of Pharmaceutical Research and Development, 5(1), 1–9. Retrieved from https://ajprd.com/index.php/journal/article/view/292

Issue

Volume 5 Issue 1st Jan-Feb 2017

Section

Review Articles

AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:

Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.

Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.

Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).