Biosimilars
Biotherapeutic products (biotherapeutics) have a successful record in treating many life-threatening and chronic diseases. The expiry of patents and/or data protection periods for a number of such biotherapeutics has ushered in an era of products that are designed to be highly “similar” to the corresponding licensed “originator” product. Based on a comprehensive head-to-head comparison and demonstrated high similarity, such products can partly rely for their licensing on safety and efficacy data obtained for the originator products. A variety of terms have been used to describe these products, including “biosimilars”, “similar biotherapeutic products”, “similar biological medicinal products” and “biosimilar products”. In 2009, the WHO Guidelines on evaluation of similar biotherapeutic products (SBPs) were adopted on the recommendation of the ECBS. This document provided the scientific principles and stepwise approach to be applied during the demonstration of similarity between a similar biotherapeutic product and its reference biotherapeutic product. In line with World Health Assembly resolution WHA67.21 on access to biotherapeutics, the revision of the 2009 guidelines has been adopted by the ECBS in April 2022 and it would result in greater flexibility and reduced regulatory burden, while continuing to ensure the quality, safety and efficacy of such products. The scope of the revised Guidelines was expanded to include the evaluation of biological products other than biotherapeutics, with a corresponding shift to the use of the term “biosimilar” rather than “similar biotherapeutic product”.
Biosimilar Standardization
Written Standards
Guidelines on evaluation of Biosimilars, TRS 1043, Annex 3
Post ECBS 2018 - WHO Questions and Answers: Similar Biotherapeutic Products. The 75th ECBS advised that the 2018 WHO Questions and Answers: similar biotherapeutic products document which was developed to complement the 2009 guidelines should now be withdrawn from the WHO website. It is a subject of review.
Reference materials
WHO international standards/reference materials have distinct and important roles to play in the development and characterization of similar biotherapeutic products. The intended purpose of these materials is described in the following article.
International Reference Preparations Catalogue
Implementation
WHO Guidelines on Evaluation of Similar Biotherapeutic Products adopted by the ECBS 2009 have been instrumental in raising awareness of the complex scientific issues related to the licensing of similar biological products. Implementation of the guidelines has become an increasingly important tool in achieving regulatory convergence.
The first workshop on Implementing "WHO Guidelines on Evaluating Similar Biotherapeutic Products (adopted in 2009)" into the regulatory and manufacturers practice at the global level was held on 24–26 August 2010 in Seoul, Republic of Korea. The workshop featured speakers from regulatory agencies from various countries, clinical and scientific experts, representatives from the biopharmaceutical industry and WHO. As the outcomes of the workshop, 26 peer reviewed manuscripts have been published as a special issue in Biologicals in September 2011. The online published articles in this issue are freely accessible to the public at the link below:
Meeting reports