Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching
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Publisher
Springer Science and Business Media LLC
Link
https://link.springer.com/content/pdf/10.1007/s40259-024-00655-4.pdf
Reference48 articles.
1. US Food and Drug Administration. Biosimilars. 2023. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. Accessed 12 Dec 2023.
2. Generics and Biosimilars Initiative. Biosimilars approved in Europe. 2023. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe. Accessed 12 Dec 2023.
3. US Food and Drug Administration. Biosimilar product information. 2023. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed 12 Dec 2023.
4. Cohen HP, Hachaichi S, Bodenmueller W, Kvien TK, Danese S, Blauvelt A. Switching from one biosimilar to another biosimilar of the same reference biologic: a systematic review of studies. BioDrugs. 2022;36:625–37.
5. European Medicines Agency and Heads of Medicines Agencies. EMA/627319/2022 Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 2023. https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf. Accessed 29 Nov 2023.
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