The World Health Organization recently held its 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals, including biosimilars was once again discussed.
WHO has proposed a biological qualifier (BQ), which would assign a four-letter alphabetic code to all biologicals [1]. However, not everybody agrees with WHO’s approach to naming.
During the meeting, which took place from 13–15 April 2015, US-based biosimilars maker Hospira stated that ‘it is essential for biosimilar drugs to be given the same non-proprietary names as original biologic[al]s to ensure that patients receive the full benefit of greater access and lower costs that these medicines can bring.’
Hospira’s global vice president for regulatory affairs, Dr Lisa Skeens, who spoke at the WHO meeting on behalf of the Generic Pharmaceuticals Association (GPhA), went on to point 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, and that
- Biosimilars have been successfully tracked in the marketplace using their brand name and other identifiers currently in place for product recognition, meaning a separate non-proprietary name is not necessary for keeping track of biosimilars once they are on the market.
Dr Joerg Windisch, Chief Science Officer at Sandoz Biopharmaceuticals and Chair of the European Generic medicines Association’s (EGA) European Biosimilars Group (EBG), agreed with Hospira’s viewpoint. He stated that while ‘the EGA appreciates the WHO INN Office’s efforts to counteract the proliferation of divergent naming schemes for biologic[al]s around the world’ ‘identification is easiest with as few and as simple elements as possible’. He also questioned whether we really have a lack of identifiers and whether another identifier really adds value or would it just increase complexity and confusion?
Dr Windisch also presented data that showed that strong systems that work are already in place in Europe, with 90% of adverse reaction reporting for biologicals being reported with brand-names. From Sandoz data he also showed that out of 285 spontaneous adverse events or adverse drug reactions (AEs/ADRs) reported for epoetin alfa only 7 (2%) were reported as unknown. For somatropin out of 1,335 AEs/ADRs reported only 22 (2%) were reported as unknown and for filgrastim out of 279 AEs/ADRs reported only 18 (2%) were reported as unknown.
He added that ‘introduction of a special system for a specific class of products disrupts this well working unified system’. Problems highlighted included:
- Any identifier which has no unambiguous meaning can cause confusion
- A random identifier of consonants is much harder to remember:
- yzxw, dpqb ...
- The likelihood is high a random identifier will be:
- misspelled or, even more likely,
- not recorded at all.
He therefore concluded that any new identifier system must therefore be tested by an independent, renowned institution in comparison to the system today (trade name or INN + company) and with all key stakeholders (physicians, pharmacists, patients, drug safety officers, etc.). This, he said, should be done in order to demonstrate it actually does improve identification and reduce safety risks.
Other groups, such as the ASBM, which represents healthcare, patient and physician groups, as well as originator biologicals companies, believe that the WHO’s BQ will prioritize patient safety. In September 2014, ASBM and 14 of its member groups submitted comments to WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability [2].
Related articles
What happened in biosimilars during 2014
WHO proposal offers clarity for biosimilar nomenclature
References
1. 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 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. More discussion over WHO biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/General/More-discussion-over-WHO-biological-qualifier
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment