FDA increases number of biological suffix proposals

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FDA increases number of biological suffix proposals

INICIO/Directrices | Posted 10/06/2016 0 Post your comment

The US Food and Drug Administration (FDA) has announced a slight change to its guidance on naming biologicals, which will allow companies to propose up to 10 suffixes for each new biological or biosimilar. The agency announced the change in a Federal Register notice released on 2 June 2016.

FDA had previously proposed in its August 2015 draft guidance on naming biologicals that each company select one random suffix [1]. It proposed 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 agency also proposed that 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.

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

In the new notice the agency says that ‘the suffix will be incorporated in the nonproprietary name of the product. The guidance recommends that applicants should submit up to 10 proposed suffixes, in the order of the applicant’s preference’.

The draft naming guidance was open for public comment until 27 October 2015, however, final guidance has not yet been issued. FDA says that most comments submitted have supported their proposal to designate a suffix. Many comments also suggested that ‘a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety and facilitate identification between biological products’. However, ‘some comments supported use of a random suffix to avoid creating an unfair advantage for specific manufacturers’.

The notice could therefore possibly allow companies to suggest meaningful suffixes, although no indication was given in the notice as to whether the proposed suffixes should be meaningful or not.

The news, does, however, follow a letter to FDA in May 2016, from 70 healthcare groups, which called for the agency to use meaningful suffixes, such as FDA used with its first biosimilar approval for Zarxio (filgrastim-sndz). The letter went on to say that ‘meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse events and specific products’. They also added that ‘a suffix based on the manufacturer name, as was used in the Zarxio approval where “-sndz” refers to “Sandoz”, also promotes manufacturer accountability’.

The agency expects to receive 40 requests annually for the proposed proper name for biologicals and six requests annually for the proposed proper name for biosimilars.

Related article
US guidelines for biosimilars

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-naming-biologicals

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Source: Federal Register, SafeBiologics