Much ado about the WHO biosimilar review

  • by: |
  • 07/29/2015

New biosimilar working paper from the WHO.

(PROPOSED ADDENDUM TO: WHO TRS 987, Annex 4. Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology  APPENDIX 7. REGULATORY)

Some important snippets:

Per clinical trials:

A head-to-head comparability exercise of a candidate similar biotherapeutic product (SBP) with a reference biotherapeutic product (RBP) is essential to justify a reduced nonclinical and clinical 26 package for licensing.

Studies should be designed to detect any potential difference in quality, nonclinical and clinical attributes between the SBP and RBP rather than simply to confirm safety and efficacy of the two products. It should be ensured that any detected differences have no clinically meaningful impact on product performance.

Per nomenclature and pharmacovigilance:

The ability of the pharmacovigilance system in the country should be considered to monitor and determine adverse reactions and/or efficacy problems (such as reduced clinical effectiveness) associated with the biotherapeutic product, should they exist.

With poor pharmacovigilance systems in many countries, as well as nomenclature difficulties, it may be impossible to obtain sufficient data to demonstrate that a particular product was the cause of an adverse reaction or that patients may be at risk from the use of products that are clinically untested or are tested with inadequately designed studies. Traceability is a key element in monitoring the safety and efficacy of biologicals as it enables pharmacovigilance measures to be put in place. 

This document is open for comments until September 14, 2015.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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