Copies of Biological Medicines: Similar But Not the Same?

Author:

Kurki PekkaORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference12 articles.

1. National Academies of Sciences. Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Ensuring Patient Access to Affordable Drug Therapies. In: Nass SJ, Madhavan G, Augustine NR, editors. Making medicines affordable: a national imperative. Washington, DC: National Academies Press; 2017. (PMID: 29620830).

2. Troien P, Newton M, Scott K, Mulligan C. The impact of biosimilar competition in Europe. IQVIA report 2021. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2021.pdf. Accessed 30 Nov 2022.

3. Kang H-N, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2021;1491:42–59.

4. Klein K, Gencoglu M, Heisterberg J, Acha V, Stolk P. The global landscape of manufacturers of follow-on biologics: an overview of five major biosimilar markets and 15 countries. BioDrugs. 2022. https://doi.org/10.1007/s40259-022-00568-0.

5. European Medicines Agency. Multidisciplinary: biosimilars. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-biosimilar. Accessed 3 Dec 2022.

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