Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Author:

Sagi SreedharORCID,Anjaneya Pradeep,Kalsekar Sameer,Kottke Andrea,Cohen Hillel P.ORCID

Funder

Sandoz International GmBH

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference32 articles.

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3. Biosimilar and Interchangeable Biologics: More Treatment Choices. U.S. Food & Drug Administration. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices#:~:text=Biosimilar%20and%20Interchangeable%20Biologics%3A%20More%20Treatment%20Choices%201,and%20Effective%20...%203%20Interchangeable%20Biosimilar%20Medications%20. Accessed 31 Aug 2023.

4. Guideline on similar biological medicinal products. Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed 31 Aug 2023.

5. Kurki P, Kang HN, Ekman N, et al. Regulatory evaluation of biosimilars: Refinement of principles based on the scientific evidence and clinical experience. BioDrugs. 2022;36:359–71. https://doi.org/10.1007/s40259-022-00533-x.

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