Assessment of Reported Adverse Events After Interchanging Between TNF-α Inhibitor Biosimilars in the WHO Pharmacovigilance Database

Author:

Pauline Orhon,Robert Marion,Bernardeau Claire,Hlavaty Alex,Fusaroli Michele,Roustit Matthieu,Cracowski Jean-Luc,Khouri CharlesORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference36 articles.

1. European Medicines Agency. Biosimilar medicines: overview. 2018. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview. Accessed 2 Dec 2022.

2. Biosimilar product information. FDA; 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed 2 Dec 2022

3. Jourdain H, Hoisnard L, Sbidian E, Zureik M. TNF-alpha inhibitors biosimilar use in France: a nationwide population-based study using the French National Health Data System. Sci Rep. 2022;12:19569.

4. Afzali A, Furtner D, Melsheimer R, Molloy PJ. The automatic substitution of biosimilars: definitions of interchangeability are not interchangeable. Adv Ther. 2021;38:2077–93.

5. Biosimilars in the EU: information guide for healthcare professionals. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcareprofessionals_en.pdf Accessed 2 Dec 2022.

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