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What’s in a Name? The US Food and Drug Administration Issues a Guidance on the Non-proprietary Naming of Biological Products

Published online by Cambridge University Press:  10 October 2017

Tobias DOLLE  and
Yury ROVNOV
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Type
Reports
Information
European Journal of Risk Regulation , Volume 8 , Issue 3 , September 2017 , pp. 559 - 564
Copyright
© Cambridge University Press 

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Footnotes

*

Tobias Dolle is an Associate and Yury Rovnov was, at the time of writing, a Junior Lawyer at FratiniVergano – European Lawyers, a law firm with offices in Brussels and Singapore that specialises in international trade and food law. An earlier version of this report appeared in Trade Perspectives©, Issue No 3 of 10 February 2017, available at <“http://www.fratinivergano.eu/en/trade-perspectives/” www.fratinivergano.eu/en/trade-perspectives/>. The authors wish to thank Ignacio Carreño and Paolo R Vergano for their valuable contributions to this article.

References

1 FDA, “Nonproprietary Naming of Biological Products, Guidance for Industry”, January 2017, available at <www.fda.gov/downloads/drugs/guidances/ucm459987.pdf> accessed 7 June 2017.

2 IMS Institute for Healthcare Informatics, “The Global Use of Medicines: Outlook through 2017”, November 2013, p 9, available at <www.imshealth.com/files/web/IMSH%20Institute/Reports/The_Global_Use_of_Medicines_2017/global use of med 2017 right6 Biologics_Market.pdf> accessed 7 June 2017.

3 IMS Institute for Healthcare Informatics, “Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets”, March 2017, pp 1 and 3, available at <www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf> accessed 7 June 2017.

4 See EMA, “Guideline on similar biological medicinal products”, 23 October 2014, p 3, item 1.1, available at <www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf> accessed 7 June 2017.

5 Supra, note 4, item 3.3.

6 Section 351(k)(4) of the PHS Act.

7 In the EU, interchangeability falls within the competence of national authorities and is therefore not addressed in the EMA guidance.

8 An additional, and by no means less significant, question is whether and how interchangeable medicines should differ in their non-proprietary names. The current FDA guidance, however, explicitly takes interchangeable products out of its scope, explaining that the “FDA is continuing to consider the appropriate […] format” for them. See FDA, “Nonproprietary Naming of Biological Products, Guidance for Industry”, supra, note 1.

9 Supra, note 8.

10 Supra, note 8, pp 4–7.

11 FDA, “Nonproprietary Naming of Biological Products, Guidance for Industry”, supra, note 1, p 9.

12 Supra, note 11, p 10.

13 ASBM, “Statement on FDA Draft Guidance ‘Nonproprietary Naming of Biological Products’”, available at <https://safebiologics.org/2015/09/asbm-statement-on-fda-draft-guidance-nonproprietary-naming-of-biological-products/> accessed 7 June 2017.

14 Generic Pharmaceutical Association, Statement by Dr Bertrand C Liang, Chairman, Biosimilars Council, “Regarding FDA Proposals on Biosimilars Naming”, 27 August 2015, available at <www.gphaonline.org/gpha-media/press/statement-by-dr-bert-c-liang-chairman-biosimilars-council-regarding-fda-proposals-on-biosimilars-naming> accessed 7 June 2017.

15 Official Journal, L 311, 28.11.2001, pp 67–128.

16 EBG, “Labelling & Naming – European Biosimilars Group (EBG) Perspective”, available at <www.medicinesforeurope.com/wp-content/uploads/2016/03/20141203_Grooten_DIA_Berlin_biosimilars.pdf> accessed 7 June 2017.

17 Supra, note 16, pp 11–18; Generics Bulletin, “Biological qualifier is not needed in the EU”, 17 October 2014, p 22.

18 EMA Press Office, “Organisational matters: Committee for Medicinal Products for Human Use meeting, 22–25 September 2014”, EMA/CHMP/129678/2014, 25 September 2014, available at <www.ema.europa.eu/docs/en_GB/document_library/Annex_to_CHMP_highlights/2014/10/WC500175252.pdf> accessed 7 June 2017.

19 WHO, “Proposal for Assignment of Biological Qualifiers (BQ)”, INN Working Doc 14.342, October 2015, p 2, available at <www.who.int/medicines/services/inn/WHO_INN_BQ_proposal_2015.pdf> accessed 20 February 2017.

20 Supra, note 19, pp 3–4.

21 Supra, note 19, pp 3–4.

22 WHO, “Biological Qualifier (BQ) Frequently Asked Questions”, INN Working Doc 15.382, October 2015, p 5, available at <www.who.int/medicines/services/inn/WHO_INN_BQ_proposal_FAQ_2015.pdf?ua=1> accessed 7 June 2017.

23 Panel Report, United States – Measures Affecting the Production and Sale of Clove Cigarettes, para 7.119.

24 See Panel Report, United States – Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, paras 7.223–7.225.

25 Supra, note 19, p 3.