Different pharmaceutical products need similar terminology

doi:10.1208/s12248-013-9532-0

. 2014 Jan;16(1):11-4.

doi: 10.1208/s12248-013-9532-0. Epub 2013 Sep 25.

Different pharmaceutical products need similar terminology

Daan J A Crommelin¹, Jon S B de Vlieger, Vera Weinstein, Stefan Mühlebach, Vinod P Shah, Huub Schellekens

Affiliations

PMID: 24065599
PMCID: PMC3889525
DOI: 10.1208/s12248-013-9532-0

Different pharmaceutical products need similar terminology

Daan J A Crommelin et al. AAPS J. 2014 Jan.

. 2014 Jan;16(1):11-4.

doi: 10.1208/s12248-013-9532-0. Epub 2013 Sep 25.

Authors

Daan J A Crommelin¹, Jon S B de Vlieger, Vera Weinstein, Stefan Mühlebach, Vinod P Shah, Huub Schellekens

Affiliation

¹ Department of Pharmaceutical Sciences, Utrecht University, P.O. Box 80.082, 3508 TB, Utrecht, The Netherlands.

PMID: 24065599
PMCID: PMC3889525
DOI: 10.1208/s12248-013-9532-0

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.

PubMed Disclaimer

Cited by

Analysis of complex drugs by comprehensive two-dimensional gas chromatography and high-resolution mass spectrometry: detailed chemical description of the active pharmaceutical ingredient sodium bituminosulfonate and its process intermediates.
Schwalb L, Tiemann O, Käfer U, Gröger T, Rüger CP, Gayko G, Zimmermann R. Schwalb L, et al. Anal Bioanal Chem. 2023 May;415(13):2471-2481. doi: 10.1007/s00216-022-04393-w. Epub 2022 Nov 19. Anal Bioanal Chem. 2023. PMID: 36401638 Free PMC article.
Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.
Dylst P, Vulto A, Simoens S. Dylst P, et al. Pharmacoeconomics. 2014 Jul;32(7):681-91. doi: 10.1007/s40273-014-0163-9. Pharmacoeconomics. 2014. PMID: 24803078
Cardiovascular, liver, and renal toxicity associated with an intravenous ferric carboxymaltose similar versus the originator compound.
Toblli JE, Cao G, Rico L, Angerosa M. Toblli JE, et al. Drug Des Devel Ther. 2017 Nov 30;11:3401-3412. doi: 10.2147/DDDT.S151162. eCollection 2017. Drug Des Devel Ther. 2017. PMID: 29238166 Free PMC article.
Use of iron sucrose and red blood cell transfusions in anaemic cancer patients in France (OncoFer study).
Luporsi E, Toledano A, Spaeth D, Scotté F, Espié M, Perot S, Duvillié L, Pithois Merli I, Bugat R. Luporsi E, et al. Support Care Cancer. 2017 Mar;25(3):973-982. doi: 10.1007/s00520-016-3489-3. Epub 2016 Dec 3. Support Care Cancer. 2017. PMID: 27915456
Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory "Astrolabe" Inspired System.
Demetzos C, Kavatzikidou P, Pippa N, Stratakis E. Demetzos C, et al. AAPS PharmSciTech. 2020 Jan 13;21(2):65. doi: 10.1208/s12249-019-1573-y. AAPS PharmSciTech. 2020. PMID: 31933006 Review.

See all "Cited by" articles

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.
1. Schellekens H, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJA. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol. 2011;59:176–183. doi: 10.1016/j.yrtph.2010.09.021. - DOI - PubMed
1. Directive 2001/83/EC, http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_pro.... Accessed 3 Dec 2012.
1. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars—why terminology matters. Nat Biotechnol. 2011;29(8):690–693. doi: 10.1038/nbt.1936. - DOI - PubMed
1. Directive 2010/84/EU, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_.... Accessed 3 Dec 2012.

MeSH terms

Actions
Actions
Actions

Substances

Actions
Actions

LinkOut - more resources

Full Text Sources
Other Literature Sources
- The Lens - Patent Citations Database
- scite Smart Citations

[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] 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.

[3] Schellekens H, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJA. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol. 2011;59:176–183. doi: 10.1016/j.yrtph.2010.09.021. - DOI - PubMed

[4] Schellekens H, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJA. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol. 2011;59:176–183. doi: 10.1016/j.yrtph.2010.09.021. - DOI - PubMed

[5] Directive 2001/83/EC, http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_pro.... Accessed 3 Dec 2012.

[6] Directive 2001/83/EC, http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_pro.... Accessed 3 Dec 2012.

[7] Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars—why terminology matters. Nat Biotechnol. 2011;29(8):690–693. doi: 10.1038/nbt.1936. - DOI - PubMed

[8] Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars—why terminology matters. Nat Biotechnol. 2011;29(8):690–693. doi: 10.1038/nbt.1936. - DOI - PubMed

[9] Directive 2010/84/EU, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_.... Accessed 3 Dec 2012.

[10] Directive 2010/84/EU, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_.... Accessed 3 Dec 2012.

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Different pharmaceutical products need similar terminology

Affiliation

Different pharmaceutical products need similar terminology

Authors

Affiliation

Abstract

Similar articles

Cited by

References

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Other Literature Sources