This is a preview of subscription content, log in via an institution to check access.
References
European Medicines Evaluation Agency. Guidelines on comparability of medicinal products containing biotechnology-derived proteins as active substance: Quality issues. EMEA/CPMP/BWP/3207/00/Rev 1. (EMEA, London, 2000).
European Medicines Evaluation Agency. Guidelines on comparability of medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. EMEA/CPMP/3097 /02/Final (EMEA, London, 2002).
Schellekens, H. Trends Biotechnol. 22, 406–410 (2004).
Bennet, C.L. et al. N. Eng. J. Med. 351, 1403–1408 (2004).
Mossinghoff, G.J. Food Drug Law J. 54, 187–194 (1999).
Schellekens, H. Nat. Rev. Drug Discov. 1, 457–462 (2002).
Louët, S. Nat. Biotechnol. 21, 956–957 (2003).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Schellekens, H. How similar do 'biosimilars' need to be?. Nat Biotechnol 22, 1357–1359 (2004). https://doi.org/10.1038/nbt1104-1357
Issue Date:
DOI: https://doi.org/10.1038/nbt1104-1357
- Springer Nature America, Inc.
This article is cited by
-
Higher-Order Structure Comparison of a Proposed Biosimilar and the Innovator Biotherapeutic Trastuzumab using Circular Dichroism Coupled with Statistical Analysis
Journal of Applied Spectroscopy (2020)
-
Hybrid mass spectrometry approaches in glycoprotein analysis and their usage in scoring biosimilarity
Nature Communications (2016)
-
Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology
Rheumatology International (2016)
-
Etanercept biosimilars
Rheumatology International (2015)
-
Biosimilar Versus Patented Erythropoietins: Learning from 5 Years of European and Japanese Experience
Applied Health Economics and Health Policy (2015)