The United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.
The FDA guidance, released in September 2015, recommends that all biologicals and biosimilars have not only non-proprietary names but also a 4-letter suffix to distinguish them from each other. The suffix would be composed of four lowercase letters and not carry any meaning [1]. Following release of the FDA guidance, industry groups, such as the Biotechnology Industry Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA) and US-based Alliance for Safe Biologic Medicines (ASBM), supported FDA’s proposal, but called for the agency to use ‘meaningful’ and ‘distinguishable’ suffixes linked to the license holder’s name [2].
However, other groups, such as the International Generic and Biosimilar Medicines Association (IGBA) which represents generics and biosimilars makers across the globe, in its comments on the draft guidance has called for biosimilars to share the same international non-proprietary name (INN) or proper name with the reference biological. The IGBA also points to the fact that Europe has almost 10 years of safe clinical experience with biosimilar products bearing the same INN as their respective reference biological.
USP is a non-profit organization which sets the drug standards that are currently enforced in the US by FDA, these standards are also used in over 140 additional countries.
‘We understand the naming approach for biologic[al]s in the Draft Guidance reflects FDA’s interest in preventing inadvertent substitution of and facilitating pharmacovigilance for biological products,’ said Dr Jaap Venema, Executive Vice President and Chief Science Officer of USP. ‘At the same time, USP believes it is critically important to maintain a uniform and scientifically-based approach that does not create unintended risks for patients and practitioners, and encourages FDA to consider alternative solutions to reach its goals.’
USP insists that the existing scientifically-based non-proprietary naming system for biologicals and other drugs has served patients and practitioners well for over a century. The naming approach proposed in FDA’s draft guidance represents a departure from well-established scientific naming principles, warns the convention, and could have unintended negative consequences.
The USP comments are in line with those of the Generic Pharmaceutical Association's (GPhA) Biosimilars Council. The GPhA claims that ‘adding a suffix … is unnecessary and does not achieve the Agency’s stated goals as it will lead to confusion among prescribers and patients’. The association argues that these products ‘have other names … for distinct recognition; including a brand name, company name, a lot number and a national drug code (NDC) number that readily distinguish [them] from other products’.
The impact of naming on pricing and market uptake of biosimilars is a longstanding area of concern, although Dr Joseph Fuhr, writing in the GaBI Journal earlier this year, concluded that it was unlikely that naming would have an impact on market uptake [3].
The full comments from USP can be found on the USP website. USP plans to comment separately on a proposed rule issue by FDA, Designation of Official Names and Proper Names for Certain Biological Products.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-naming-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Comments-on-FDA-s-guidance-on-naming-biologicals
3. Fuhr JP, Chandra A, Romley J, et al. Product naming, pricing, and market uptake of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):64-71. Available from:
www.gabi-journal.net/product-naming-pricing-and-market-uptake-of-biosimilars
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