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 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:
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.