Tuesday, October 22, 2013
Geneva, Switzerland (Oct. 22, 2013)
— At today’s World Health Organization (WHO) 57th Consultation on International Nonproprietary Names, an open forum for discussion among stakeholders, the Generic Pharmaceutical Association reiterated its call for a consistent, proven international standard for biosimilar naming.
“Biosimilars represent an enormous opportunity to put many of today’s most life-changing medicines in reach for millions more patients,” said Ralph G. Neas President and CEO of GPhA. “It is critical that any decision on naming these products does not jeopardize that potential. That is why we are so pleased that WHO is taking a thoughtful and deliberate approach to reviewing this issue.”
GPhA joined the European Generics Association (EGA) in stressing that the established INN naming system has worked effectively and should be continued. The presentation noted that for more than 50 years, this system has successfully identified drug products and assured practitioners worldwide that the prescribed product has the same active ingredient and clinical effect as the reference product. EGA and GPhA also remarked that their members have successfully and safely produced biosimilars for patients over the past seven years.
GPhA recommended that all biosimilars share the same international nonproprietary name (INN) as the biologic products to which they refer, because by definition they are “highly similar” to the reference biologics and have no clinically meaningful differences that require a unique name. Adding further layers of requirements, GPhA warned, would likely create confusion, slow adoption of biosimilars, and potentially give rise to medical errors.
This position is shared by GPhA and EGA member company Hospira, which recently released a new policy paper on biosimilars naming, “What’s in a Name? The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation,” by Sumant Ramachandra, MD, PhD. Ramachandra presented on behalf of GPhA at today’s meeting along with David Gaugh, GPhA Senior Vice President, Sciences and Regulatory Affairs.
Biosimilars one pager
Hospira press release
GPhA Citizen Petition (full)
Summary: GPhA citizen petition on biosimilar naming