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Biosimilars: the science of extrapolation
Abstract
Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal products (so-called “biosimilars”) and the approval of several biosimilars in the European Union, acceptance of biosimilars in the medical community continues to be low. This is especially true in therapeutic indications for which no specific clinical trials with the biosimilar have been performed and that have been licensed based on extrapolation of efficacy and safety data from other indications. This article addresses the concerns frequently raised in the medical community about the use of biosimilars in such extrapolated indications and explains the underlying scientific and regulatory decision making including some real-life examples from recently licensed biosimilars.
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Cited by
Jørgensen, K. K., Olsen, I. C., Goll, G. L., Lorentzen, M., Bolstad, N., Haavardsholm, E. A., Lundin, K. E. A., Mørk, C., Jahnsen, J., Kvien, T. K., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(17)30068-5 · Cited by 818
Progress in biopharmaceutical development
Kesik‐Brodacka, M. (2018) · Biotechnology and Applied Biochemistry · doi:10.1002/bab.1617 · Cited by 353
Ha, T. K., Kim, D., Kim, C. L., Grav, L. M., & Lee, G. M. (2022) · Biotechnology Advances · doi:10.1016/j.biotechadv.2021.107831 · Cited by 74
Metadata
- Authors
- Weise, M., Kurki, P., Wolff-Holz, E., Bielsky, M.-C., & Schneider, C. K.
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2014-11-20
- Volume
- 124
- Issue
- 22
- Pages
- 3191-3196
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- OpenAlex
- W2023193839
- Cited by
- 307
- References
- 0
- FWCI
- 18.02
- Type
- journal article
- Language
- en
- Open access
- closed
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- Weise, M., Kurki, P., Wolff-Holz, E., Bielsky, M.-C., & Schneider, C. K. (2014). Biosimilars: the science of extrapolation. Blood. https://doi.org/10.1182/blood-2014-06-583617
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
