GPhA commends IGBA for persuading WHO evaluation of BQ impact

The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council released a statement last week from its President and CEO, Chip Davis, commending the International Generic and Biosimilar Medicines Association (IGBA) for persuading the World Health Organization (WHO) to carry out an evaluation of the global impact for the voluntary biologic qualifier (BQ) proposal for the quality, safety and access to biologic products.

The addition of a random BQ assigned to the international nonproprietary name (INN) for biologics is not currently supported by the GPhA Biosimilars Council. The IGBA has the same concerns as the council that WHO will require an additional amount of time to evaluate the worldwide impact of the Biolsimilars Council’s BQ proposal.

The council has expressed to WHO the urgency of extending the timeline for the evaluation so it can properly consider the full spectrum of concerns surrounding the implementation of the BQ approach. This includes the underlying rationale, which has been called questionable, the uncertainty of the retrospective application, the opportunity to limit competition and the potential to damage provider confidence in regards to the safety and effectiveness of biosimilar products.