In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.
On 14 August 2014, more than 10 medical associations and 20 individual specialists sent a signed letter to the US Food and Drug Administration (FDA) Commissioner Margaret Hamburg saying that biosimilars ‘must have distinguishable non-proprietary names’.
Their reasons, outlined in the letter, include:
- A biosimilar will only be similar, but not identical to the reference product, therefore, distinct non-proprietary names will help to alert physicians that each product, while safe and effective, may differ slightly.
- A recent survey [1] of physicians who prescribe biologicals and biosimilars in Europe indicated that 61% of the respondents believed that if two products shared an International Nonproprietary Name (INN), they were approved for all of the same indications, which is not necessarily the case.
- Distinguishable names will help prevent inappropriate pooling of adverse events by clearly identifying which product a patient was prescribed.
- In light of the perception among many physicians that a shared non-proprietary name implies approval for all of the same indications, FDA’s decision on interchangeability between indications may largely be rendered moot once biosimilars enter the US marketplace, if the biosimilar shares a non-proprietary name with the reference product.
On the other hand, on 1 July 2014, 32 organizations, which included pharmacies, labour unions, state retirement systems and payors, wrote to FDA to require biologicals and biosimilars to have the same INN [2]. In their letter, they stated that they ‘believe that the current mechanisms in place [e.g. national drug code (NDC), lot number, brand name, manufacturer, etc.] are sufficient.’
The World Health Organization is also considering the use of a biological qualifier (possibly a four-letter code) to distinguish biosimilars [3]. While the Generic Pharmaceutical Association has proposed using manufacturer names to distinguish biosimilars as a compromise [4].
The debate seems is not over yet, but time is running out for FDA. With the submission of two applications via the abbreviated biosimilars pathway [5, 6], FDA needs to make a decision soon on naming of biosimilars.
Related articles
WHO proposal offers clarity for biosimilar nomenclature
European doctors have insufficient knowledge of biosimilars
Naming and interchangeability of biosimilars raised in new survey
References
1. Dolinar RO, Reilly MS. Biosimilars naming, label transparency and authority of choice – survey findings among European physicians. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;3(2):58-62. doi: 10.5639/gabij.2014.0302.018
2. GaBI Online - Generics and Biosimilars Initiative. 32 organizations agree biosimilars should have same names [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/General/32-organizations-agree-biosimilars-should-have-same-names
3. GaBI Online - Generics and Biosimilars Initiative. WHO investigates use of a biological qualifier for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. GPhA proposes using manufacturer names to distinguish biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/General/GPhA-proposes-using-manufacturer-names-to-distinguish-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application
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