FDA issues draft guidance on naming biologicals

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FDA issues draft guidance on naming biologicals

INICIO/Directrices | Posted 04/09/2015 0 Post your comment

The US Food and Drug Administration (FDA) has issued another draft guidance for biosimilars. The draft guideline, issued on 27 August 2015, details the FDA’s proposal on the non-proprietary naming of biological products.

FDA is proposing that all biologicals and biosimilars have non-proprietary names and that a 4-letter suffix be added to the names to distinguish them from each other. The suffix would be composed of four lowercase letters, and not carry any meaning. For example, the non-proprietary name of a reference product could be replicamab-cznm and a biosimilar to that product could be replicamab-hixf.

The proposed draft guidance on naming should, according to FDA, ‘help prevent inadvertent substitution’ of non-interchangeable products and make it easier ‘to accurately track usage of biological products’.

Nonproprietary naming of biological products
Date: August 2015
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

There may be many opponents to the guidance, as biosimilars makers would prefer to use the same non-proprietary names as the brand-name biologicals without any suffix, while originator manufacturers would prefer completely different names. The Generic Pharmaceutical Association (GPhA) thinks that the guidance warrants ‘serious scrutiny’ because of its potential ‘to erect barriers to patient access to new, more affordable medicines, and jeopardize their safety’. GPhA has previously pointed out that Europe has approved biosimilars with the same non-proprietary names as their reference biologicals for more than six years in a system that has proved effective [1]. They add that ‘adverse events and product recalls for small-molecule and biologic[al] drugs already are successfully identified using the national drug code, and lot number and company name, and there is no compelling evidence that biosimilars should be handled differently’.

The Academy of Managed Care Pharmacy (AMCP) has also issued a statement calling the draft guidance ‘disappointing’. AMCP CEO Ms Edith A Rosato said that ‘AMCP is concerned that any departure from the currently accepted non-proprietary naming system will create confusion amongst healthcare practitioners and patients, have negative effects on the ability to ensure safe dispensing and tracking, and result in lower market adoption and cost-savings’.

The American College of Rheumatology (ACR), on the other hand, has announced its support for the guidance, saying that it supports the ACR’s position statement [2], which advocates ‘distinctive names that would distinguish the biosimilar agent from its originator substance’.

FDA officials also stated that the agency must consider what to do ‘to address previously approved biological products that do not have a suffix’. The agency is seeking public comment on the draft guidance document. Comments and suggestions should be submitted within 60 days of publication in the Federal Register, i.e. by 27 October 2015.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Arguments for same INN for biosimilars presented at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/Arguments-for-same-INN-for-biosimilars-presented-at-WHO-meeting
2. GaBI Online - Generics and Biosimilars Initiative. ACR position statement on biosimilars addresses naming and substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/ACR-position-statement-on-biosimilars-addresses-naming-and-substitution

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Source: AMCP, US FDA, Federal Register