At the 14th Annual Biosimilars Group Conference, Dr Daisaku Sato, Director, Office of Cellular and Tissue-based Products at the Pharmaceutical and Medical Devices Agency (PMDA), discussed naming rules and interchangeability for biosimilars in Japan [1].
Regulations in Japan require that biosimilars of complex protein products bear unique non-proprietary names. The naming convention requires the biosimilar to use the non-proprietary name of the reference product, plus ‘biosimilar’ and a number indicating the order in which the biosimilar was approved in Japan, i.e. using the following format:
### (genetical recombination) [XXX biosimilar 1 (2, 3, ···)]
Such names are then termed the Japanese Accepted Name (JAN). The JAN is given in accordance with PFSB Notification No.0331001/ March 31 2006. Examples include epoetin kappa (genetical recombination) [epoetin alfa biosimilar 1], filgrastim (genetical recombination) [filgrastim biosimilar 1], filgrastim (genetical recombination) [filgrastim biosimilar 2], and filgrastim (genetical recombination) [filgrastim biosimilar 3] [2]. One exception is the case of non-glycosylated proteins, which can use the same JAN as the reference product.
The issue of naming for biologicals is a contentious one. The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [3]. However, not everyone agrees with their proposal [4]. The US Food and Drug Administration (FDA) has also gone down this road, so far assigning a 4-letter suffix to approved biosimilars [5]. The European Medicines Agency (EMA), on the other hand, has approved biosimilars since 2006 using the same non-proprietary names as the brand-name biologicals. The majority of EU Member States strongly support that biosimilars should be closely aligned with their reference product and that it is not problematic to identify biologicals which are subject to adverse reaction reports [6].
With respect to the interchangeability of biosimilars, Japanese regulation does not give a definition of interchangeability for biosimilars. The naming system does not allow for substitution of biosimilars at the pharmacy level. Switching to a biosimilar is therefore dependent on the decision of the physician and is not restriction by regulation.
In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by EMA, but at the national level. This is despite the fact that biosimilars developed in line with EU requirements are considered by EMA to be therapeutic alternatives to their reference biologicals [7]. Germany, France and Finland have made specific recommendations concerning interchangeability of biosimilars.
Editor’s comment
Readers interested to learn more about naming of biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
The biosimilar name debate: what’s at stake for public health
The challenges of nomenclature – INN, biosimilars and biological qualifiers
Readers interested in contributing a research article or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
If you would like to receive a PDF copy* of the Daisaku presentation [1], please send us an email.
*For profit organizations subjected to a fee
Related articles
Extrapolation of indications for biosimilars in Japan
Reference products and toxicity studies for biosimilars in Japan
Regulation of biosimilars in Japan
References
1. Daisaku S. Surfing the wave in Japan for regulatory convergence of biosimilar. 14th Annual Biosimilar Medicines Group Conference; 28-29 April 2016; London.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan
3. GaBI Online - Generics and Biosimilars Initiative. WHO issues draft proposal for its biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Policies-Legislation/WHO-issues-draft-proposal-for-its-biological-qualifier
4. GaBI Online - Generics and Biosimilars Initiative. IGBA opposes WHO biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/IGBA-opposes-WHO-biological-qualifier
5. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/Comments-on-FDA-s-guidance-on-naming-biologicals
6. 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 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars and interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-and-interchangeability
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 © 2016 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment