NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.
In a letter to the WHO sent in conjunction with the 57th Individual Nonproprietary Name Consultation, which ended Thursday, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association said they were "concerned" about efforts to give biosimilars different generic names from their branded counterparts.
"The proposal surrounding a word identifier plus a fantasy suffix, or a two-part name, is concerning to our organizations," read the letter, addressed to INN program manager Balocco Mattavelli and signed by APhA SVP pharmacy practice and government affairs Stacie Maass, NACDS VP public policy and regulatory affairs Kevin Nicholson and NCPA VP policy and regulatory affairs Ronna Hauser. "To avoid a naming convention that may create confusion, our organizations have previously recommended that biosimilar products maintain the same name as their reference biologic counterparts and not use suffixes."
The generic names used for biosimilars have emerged as a contentious issue as the Food and Drug Administration prepares to implement the abbreviated regulatory approval pathway for them, as mandated by the Patient Protection and Affordable Care Act of 2010. Biotech companies, which stand to lose billions in sales when cheaper biosimilar versions of their products enter the market, maintain that because biosimilars will be made using separate cell lines from their branded counterparts, there is a risk that they will be different in terms of safety and efficacy, but generic drug makers reject these claims, pointing to the six years in which biosimilars have been available in the European market.
Also, in a paper recently presented to the WHO, Hospira SVP and chief scientific officer Sumant Ramachandra noted that European regulators had approved biosimilars with the same generic names as their reference biologics for more than six years in a system that had proved effective.