REGULATORY REQUIREMENTS OF ‘SIMILAR BIOLOGICS’ FOR MARKETING AUTHORIZATION IN INDIA

  • Sharmila V. Reddy
  • Mounica N.V.N
  • Anusha S.
  • Evangeline L.
  • Nagabhushanam M.V.
  • Nagarjunareddy D.
  • Brahmaiah B.

Abstract

Present article signifies the exigency for regulation and regulatory bodies involved in development of biosimilars. The principle for development of biosimilars included opting adequate reference product, manufacturing process optimization, quality control procedure, preclinical and clinical studies. India’s first guidelines were enforced in 2012, with amendments in 2016. Thus, we elaborated the amended guidelines for development of biosimilars.

Keywords: Biosimilars; CDSCO, IBSC, Manufacturing; Stability; Efficacy; India Guidelines.

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References

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How to Cite
Reddy, S. V., M. N.V.N, A. S., E. L., N. M.V., N. D., and B. B. “REGULATORY REQUIREMENTS OF ‘SIMILAR BIOLOGICS’ FOR MARKETING AUTHORIZATION IN INDIA”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 1, Feb. 2018, pp. 20-24, doi:10.22270/ijdra.v5i1.193.

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