January 28, 2016 BPC Statement on WHO Biosimilar Naming Decision

On January 26th, 2016, the World Health Organization (WHO) finalized its biosimilar naming decision, or Biological Qualifier scheme, for the Programme on International Nonproprietary Names (INN). The scheme calls for each biologic, including biosimilars, to be assigned a randomized four-consonant “biological qualifier” (BQ), making it possible to trace the compounds globally. Each biosimilar will be assigned a BQ at random by an automated online system.

The Biologics Prescribers Collaborative (BPC) applauds WHO for acknowledging the need for biosimilars to be assigned a distinguishable qualifier to build physician confidence, ensure patient safety and promote a robust biosimilar market.

As the U.S. Food and Drug Administration (FDA) works to finalize its naming guidance, we reiterate our support for FDA’s proposal that all biological products bear a distinguishable four-letter suffix but urge the agency to also ensure that the suffixes be meaningful, greatly enhancing pharmacovigilance, patient safety and transparency.

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