Stakeholders question FDA’s guidance on naming biologicals

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In March 2019, the US Food and Drug Administration (FDA) issued a new draft guidance document concerning non-proprietary name suffixes for biological products [1]. Many stakeholders comments on the document call for a change in policy from the agency when it comes to naming biologicals.


In its March 2019 draft guidance, FDA introduced three key changes to its approach to non-proprietary name suffixes. Firstly, and perhaps most importantly, already approved biologicals would not be required to revise their names. However, the agency will continue to assign suffixes to newly approved originator biologicals, biosimilars or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products, such as insulin. These are products that are currently approved under New Drug Applications (NDAs) rather than Biologic License Applications (BLAs). In March 2020, however, these existing NDAs will be converted to BLAs [1].

The comment period on the new draft naming guidance ended on 7 May 2019 and comments from many stakeholders have requested a change of policy from the agency, with many saying that this proposal will create a two-tier, ‘confusing’ system of naming.

The Federal Trade Commission is concerned ‘that disparate treatment and differentiated naming of certain biosimilar products will reduce biosimilar competition in the United States’. The Commission went on to say that FDA’s proposed naming guidance ‘would likely create unnecessary barriers to entry for lower cost biologic[al] products that are biosimilar to or interchangeable with existing FDA-approved biologic[al] products’.

The US Pharmacopeia (USP) says that it understands ‘that the naming approach for biologic[al]s in the Draft Guidance reflects FDA's interest in preventing inadvertent substitution of and facilitating pharmacovigilance for biological products’. However, it ‘believes it is critically important to maintain a uniform and scientifically based naming approach that does not create unintended risks for patients and practitioners’. The 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.

America’s Health Insurance Plans (AHIP) said in its comments that the approach being contemplated in the proposed guidance ‘is seriously flawed and would … cause provider and patient confusion about the safety and effectiveness of biosimilars’. They also believe that the proposal would ‘undermine FDA’s goals of supporting and strengthening the biosimilars market and is inconsistent with the regulatory approach adopted by other developed, industrialized countries with vibrant and competitive biosimilar markets’.

The AHIP recommends, as an alternative, that FDA moves forward with an alternative regulatory approach that applies a uniform non-proprietary naming convention across all biological products without adopting the confusing and random suffix.

The Biosimilars Forum, a non-profit organization whose mission is to promote biosimilars-related education and policy advancement in the US, also ‘has significant concerns that the revised draft guidance for the naming convention of biologic[al]s will promote an unsubstantiated notion that strict pharmacovigilance is only essential for biosimilars. The revised policy will likely not enhance FDA’s already rigorous safety standards, and we are concerned it will continue to fuel misinformed ideas about biosimilars’.

Some go even further, with Sandoz, the generics division of Novartis, stating that ‘It is not necessary to modify the existing naming system that has worked well for over 60 years. Biosimilars and interchangeable biologic[al]s should share the same non-proprietary name as their respective reference products. Introduction of suffixes to the non-proprietary names of biologic[al]s is not necessary and may even be problematic’.

Biosimilars developer Mylan agrees with this view, saying that ‘these suffixes are not necessary and, worse, generate confusion by departing from usual naming conventions in the US (including for other biologic[al]s already approved by FDA that share non-proprietary names) and elsewhere, and giving the appearance of difference when none exists’.

The International Generic and Biosimilar medicines Association (IGBA) is also strongly urging FDA to ‘re-evaluate the use of a product-specific suffix for biologic[al]s naming given the growing evidence base that suffixes are not necessary for robust pharmacovigilance and product identification’. The IGBA goes on to state that the ‘proposed two-tier naming system undermines FDA’s rationale and creates confusion and risk’. The association also pointed out that ‘the FDA has confirmed that there is no inherent safety concern with licensed biologic[al]s sharing non-proprietary names. Indeed, a 2013 review found 77 FDA-licensed biologic[al] products (including products approved under the PHSA and those that will be deemed to be licensed under the PHSA [(Provincial Health Services Authority)] as of March 2020) shared 25 non-proprietary names, with no resulting safety issues’. Based on this evidence, they say that ‘the decision to apply a product-specific suffix approach to future biologic[al] products, including biosimilar medicines, seems illogical, inconsistent and unfounded’.

The IGBA therefore concludes that ‘if retrospective application is too complicated and costly to implement, as the 2019 Naming guidance update suggests, the suffix-based system must be removed for all biologic[al]s, including biosimilar medicines’.

Related articles
FDA update on naming biologicals

Biosimilar naming in the US, the debate continues

1. GaBI Online - Generics and Biosimilars Initiative. FDA proposes update to biosimilar naming guideline []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 24]. Available from:

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Source: AHIP, IGBA, Mylan, Federal Register, FTC, The Biosimilars Forum, US FDA

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