Regulatory challenges with biosimilars: an update from 20 countries.

Annals of the New York Academy of Sciences
Hye-Na KangTeruhide Yamaguchi

Abstract

The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for g...Continue Reading

References

Oct 2, 2004·The New England Journal of Medicine·Charles L BennettNicole Casadevall
Mar 25, 2011·Kidney International·Kearkiat PraditpornsilpaSomchai Eiam-Ong
Aug 9, 2011·Nature Biotechnology·Martina WeiseChristian K Schneider
Sep 2, 2011·Biologicals : Journal of the International Association of Biological Standardization·Hye-Na Kang
Sep 13, 2011·Biologicals : Journal of the International Association of Biological Standardization·Meenu WadhwaElwyn Griffiths
Apr 27, 2018·Bulletin of the World Health Organization·Hye-Na Kang, Ivana Knezevic
Nov 2, 2019·Biologicals : Journal of the International Association of Biological Standardization·Robin ThorpeIvana Knezevic
Jan 22, 2020·Biologicals : Journal of the International Association of Biological Standardization·Meenu WadhwaMinae Yun
Apr 1, 2020·Biologicals : Journal of the International Association of Biological Standardization·Hye-Na KangUNKNOWN Survey participants from 19 countries

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