by Brian Kennedy, Executive Director
On behalf of the Global Alliance for Patient Access I participated in this week’s International Nonproprietary Names (INN) Biological Qualifier (BQ) Comments Review: Front Page Meeting with Stakeholders, held at the World Health Organization Headquarters in Geneva, Switzerland.
The WHO’s INN Expert Group faces a significant challenge, as reflected in this week’s meeting and the most recent proposal. The group must develop a simple solution to a complex matter, a solution that will be broadly supported and voluntarily adopted by regulatory authorities such as the FDA and its counterparts throughout the world.
The meeting allowed the WHO to solicit and review feedback from stakeholders on that solution, as it’s now articulated in the 2nd Proposal for Assignment of Biological Qualifiers. The proposal covers all biotherapeutic products and provides for them to be given a distinct qualifier, a four-letter suffix that accompanies each product’s nonproprietary name.
The FDA followed a similar approach with filgrastim-SNDZ, the first therapy approved under the new U.S. biosimilar pathway. The current WHO proposal’s approach differs slightly. Upon approval of the manufacturer’s application, it would assign the suffix as a random, computer-generated, four-consonant code. It would not identify the product’s manufacturer as the FDA’s approach did. (“SNDZ” refers to Sandoz.)
WHO’s hope is that this simple approach will allow physicians and pharmacists to readily identify the products being prescribed and dispensed, enabling them to monitor any adverse reactions if a patient switches between similar biotherapeutics. It could also help put an end to one of the most vexing policy questions surrounding biologic therapies and their biosimilar counterparts: How should they be named?
If Tuesday’s meeting was any indication, WHO’s progress is being followed closely by governments and manufacturers, but also by patient advocates and health care providers. Well over 100 stakeholders had submitted comments and either attended Tuesday’s session or participated via Webex. Patient advocates joining GAfPA in Geneva included the Global Healthy Living Foundation, the Alliance for Safe Biologic Medicines and the Global Colon Cancer Alliance.
While the Expert Committee has many important questions to consider before adopting a final proposal, it appears that WHO is on course to approve a BQ scheme this year. However, as WHO officials presiding on Tuesday made clear, the system is voluntary; each country’s Drug Regulation Authority decides whether to utilize the BQ when approving biotherapies.
Going forward, therefore, the challenge will fall to health care providers and patient advocates to educate policymakers about the need for biological medicines to have distinct names and the benefits of a globally harmonized approach to nomenclature.
More at Institute for Patient Access