The WHO’s Expert Committee on Biological Standardisation (ECBS) has declined a request to revise its 2009 Guidelines for the Evaluation of Similar Biotherapeutic Products (WHO Guidelines), which set the requirements for the generic version of biotherapeutics known as “biosimilars”.
The WHO Secretariat then decided to evaluate the scientific evidence to support the revision of WHO Guidelines. The procedural holes in the ECBS decision might be the reason behind WHO’s decision to review the scientific evidence.
During its 70th meeting on 21-25 October 2019 the ECBS – which includes a panel of experts with proficiency in developing norms and standards related to vaccines, blood products, and biotherapeutics – considered a request initiated by a group of scientists and civil society organisations (CSO) to revise the WHO Guidelines on biosimilars.