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.
Similar content being viewed by others
References
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.
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.
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.
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.
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.
The Biologics Price Competition and Innovation Act, BPCI act. 2009. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ucm216146.pdf. Accessed 3 Dec 2012.
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.
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.
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.
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.
Konski AT. Generic biologics, a comparative analysis of regulatory review. BioProcess Int. 2011;9:34–40.
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.
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.
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.
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
Corresponding author
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
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1208/s12248-013-9532-0