Affiliation:
1. World Health Organization, Access to Medicines and Health Products Geneva Switzerland
2. Medicines and Healthcare products Regulatory Agency Potters Bar UK
3. Independent Consultant Surrey UK
Abstract
AbstractTechnological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars. Among the revisions, there is more reliance on analytical and functional aspects to prove similarity (and likely fewer clinical requirements). WHO international reference standards for biosimilars provide additional confidence to regulators looking for evidence‐ and data‐based regulatory convergence in scientific and technical measures of quality attributes. These standards serve as a benchmark for harmonizing the bioactivity or potency of biosimilars, ensuring their future sustainability. This article discusses the availability and role of WHO international reference standards throughout the product life cycle of biosimilars.
Reference45 articles.
1. Intended use of reference products and WHO international standards/reference reagents in the development of similar biological products (biosimilars);Thorpe R.;Biologicals,2011
2. World Health Organization. (2006).Recommendations for the preparation characterization and establishment of international and other biological reference standards. In:WHO Expert Committee on Biological Standardization: Fifty‐Fifth Report. Annex 2 (WHO Technical Report Series No. 932).Geneva:World Health Organization.
3. Role of public standards in the safety and efficacy of biologic medicines;Williams R. L.;AAPS Journal [Electronic Resource],2014
4. Primary and secondary reference materials for procedures to test the quality of medicines and foods;Hauck W. W.;Pharmaceutical Research,2012