Skip to main content
Log in

Different Pharmaceutical Products Need Similar Terminology

  • Commentary
  • Published:
The AAPS Journal Aims and scope Submit manuscript

Abstract

In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) and offers a proposal for a globally accepted terminology regarding (non-) biological complex drugs.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. FDA, Drug Price Competition and Patent Term Restoration Act of 1984 PL 98–417 (Sept. 24, 1984) Available via htpp://www.fda.gov Accessed 3 Dec 2012.

  2. Schellekens H, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJA. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol. 2011;59:176–83.

    Article  CAS  PubMed  Google Scholar 

  3. Directive 2001/83/EC, http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004481.pdf. Accessed 3 Dec 2012.

  4. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars—why terminology matters. Nat Biotechnol. 2011;29(8):690–3.

    Article  CAS  PubMed  Google Scholar 

  5. Directive 2010/84/EU, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf. Accessed 3 Dec 2012.

  6. The Biologics Price Competition and Innovation Act, BPCI act. 2009. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ucm216146.pdf. Accessed 3 Dec 2012.

  7. FDA. 2012. Scientific considerations in demonstrating biosimilarity to a reference product http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed 3 Dec 2012.

  8. FDA. 2012. Quality considerations in demonstrating biosimilarity to a reference protein product http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf. Accessed 3 Dec 2012.

  9. FDA. 2012. Biosimilars: questions and answers regarding implementation of the BPCI act http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf. Accessed 3 Dec 2012.

  10. Chow SC, Endrenyi L, Lachenbruch PA, Yang LY, Chi E. Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars. 2011;1:13–26.

    Google Scholar 

  11. Konski AT. Generic biologics, a comparative analysis of regulatory review. BioProcess Int. 2011;9:34–40.

    Google Scholar 

  12. WHO 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed 3 Dec 2012.

  13. Ehmann F, Saka-Kato K, Duncan R, Hernan Perez de la Ossa D, Pita R, Vidal J-M, et al. Next generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines. Nanomedicine. 2013;8:849–56.

    Article  CAS  PubMed  Google Scholar 

  14. Borchard G, Flühmann B, Mühlebach S. Nanoparticle iron medicinal products—requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Reg Tox Pharm. 2012;64:324–8.

    Article  CAS  Google Scholar 

Download references

Acknowledgments

This paper was written within the framework of the Non Biological Complex Drugs Working Group, hosted at TI Pharma. The NBCD Working Group is currently supported by Vifor Pharma International Inc., Teva Pharmaceutical Industries Ltd., and Sanofi-Aventis Groupe. The group encourages further scientific discussion and multidisciplinary research between experts in the different fields from academia, industry and regulatory bodies including consensus discussions with all stakeholders on an international level. The authors acknowledge the valuable support from those stakeholders who filled out the terminology questionnaire.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Huub Schellekens.

Additional information

All authors are members of the Non Biological Complex Drugs Working Group hosted at TI Pharma, P.O. Box 142, 2300AC Leiden, The Netherlands

Electronic supplementary material

Below is the link to the electronic supplementary material.

ESM 1

(PDF 119 kb)

Rights and permissions

Reprints and permissions

About this article

Cite this article

Crommelin, D.J.A., de Vlieger, J.S.B., Weinstein, V. et al. Different Pharmaceutical Products Need Similar Terminology. AAPS J 16, 11–14 (2014). https://doi.org/10.1208/s12248-013-9532-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1208/s12248-013-9532-0

KEY WORDS

Navigation