WHO Invites Comments on Biosimilars Q&A

The World Health Organization (WHO) has produced a draft Question and Answer (Q&A) document that gives additional clarification to its 2009 guidelines for evaluating similar biotherapeutic products, particularly with respect to evaluating biosimilars of monoclonal antibodies.

The contents of the draft document, which the WHO emphasizes must be read in the context of the guidelines, were selected on the basis of the questions most frequently asked by regulators during implementation workshops for the WHO guideline document, which seeks to provide globally acceptable principles for the licensing of follow-on biologics (except for vaccines and plasma-derived products, for which the organization provides separate recommendations and guidance). The WHO says that the guidelines can be adopted in whole or in part by any national regulatory authority worldwide.

The Q&A follows 6 broad categories: the concept for licensing similar biotherapeutic products, reference biotherapeutic products, quality, nonclinical evaluation, clinical evaluation, and pharmacovigilance. Topics addressed in the Q&A range from basic definitions of terms such as “similar biotherapeutic product” and “reference biotherapeutic product” to more technical issues, such as how many batches of a product should be tested in comparability studies, how comprehensive an evaluation of glycan structure should be, and how updates to safety information for a reference product should be handled for approved biosimilars, among others.

The WHO invites stakeholders to submit written comments on the draft to the Department of Essential Medicines and Health Products by September 20, 2018. After the organization’s Expert Committee on Biological Standardization has had the opportunity to review the comments and discuss any alterations to the document, the outcome of its deliberations will be published in the WHO Technical Report Series.

Additional initiatives of the WHO on promoting biosimilars include its pilot program to prequalify biosimilars for oncology indications. In May 2017, the organization announced that it would launch the pilot, which intended to expand access to some of the most expensive biologics in low- and middle-income countries.

Under the program, if the WHO finds that a biosimilar is comparable to its reference in terms of quality, safety, and efficacy, WHO will list the product, making it eligible for procurement by United Nations agencies. It will also allow some middle- and low-income countries that rely on WHO prequalification to make the listed biosimilar available to patients.