WHO Will Not Proceed With Biological Qualifiers for Biosimilars

The World Health Organization (WHO) has announced that, at present, it will not proceed with its proposal to use biological qualifiers (BQ) to assign international nonproprietary names to biosimilars.

The announcement was part of an October 2017 WHO publication, “Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products,” which covered a May 2017 meeting held in Geneva, Switzerland, to address concerns about improving access to, education about, and the use of biosimilars. The expert consultation was convened by WHO to gather stakeholder opinions regarding policy initiatives, technical requirements for manufacturing, regulatory support tools such as potential BQs, and building trust in biosimilars.

The October report noted that no consensus was reached during the meeting on whether WHO should move forward with the BQ; the system would have been similar to the system used by the FDA, which assigns biosimilars nonproprietary names that have non-meaningful 4-letter suffixes that distinguish them from originator or other biosimilar products. The Biosimilars Council, a trade group for biosimilar manufacturers, praised WHO’s announcement on Twitter, saying that then use of an added identifier for biosimilar drugs would act as an additional barrier to both patient access and cost savings.

At the May meeting, WHO decided to proceed with a separate project, a pilot concerning the prequalification (PQ) of 2 biosimilar cancer therapeutics—rituximab and trastuzumab. The aim of the project is to use 2 assessment pathways for biosimilar applicants: the first based on biosimilars with approvals from a Stringent Regulatory Authority (SRA), and the other a pathway for applicants approved by other national regulatory authorities. WHO will provide clear guidance to manufacturers wishing to apply for the pilot project.

The May meeting also addressed interchangeability of biosimilars with originator biologics, the complexities and diversities of nomenclature, and the principle of biosimilarity. Lessons learned and recent experiences with biosimilars were presented by representatives from Australia, Norway, India, and Brazil. The meeting also included presenters from the pharmaceutical industry, patient groups, and professional societies, who offered a wide range of perspectives on recurrent themes:

• The need to ensure biosimilar quality, safety, and efficacy, notably through robust regulation and guidance
• The need for clarity regarding nomenclature and terminology
• The need for education regarding biosimilars, including effective communication

In addition to the announcement concerning the BQ and the pilot programs for rituximab and trastuzumab biosimilars, WHO concluded that the organization will review and provide clarification on the organization’s 2009 biosimilar guidelines to reflect technological and analytical advances and experience gained in the following years.