Stepping Forward to the Next Level: Totality of Evidence for the First High-Concentration Adalimumab Biosimilar, CT-P17

Author:

Viapiana Ombretta,Lee SoohyunORCID,Yoon SangWookORCID,Fautrel BrunoORCID

Funder

Celltrion Healthcare

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),General Medicine

Reference33 articles.

1. Bellinvia S, Cummings JRF, Ardern-Jones MR, et al. Adalimumab biosimilars in Europe: an overview of the clinical evidence. BioDrugs. 2019;33:241–53.

2. Fusaro E, Durez P, Wohlrab J, et al. An update on the adalimumab biosimilar landscape following the approval of the first high-concentration biosimilar. Immunotherapy. 2021. https://doi.org/10.2217/imt-2021-0271 (Epub ahead of print).

3. US Food and Drug Administration. Humira: CBER approval letter. 2002. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm. Accessed 16 November 2021.

4. European Medicines Agency. Humira: scientific discussion. 2004. Available at: https://www.ema.europa.eu/en/documents/scientific-discussion/humira-epar-scientific-discussion_en.pdf. Accessed 16 November 2021.

5. European Medicines Agency. Humira: procedural steps taken before authorisation. 2005. https://www.ema.europa.eu/en/documents/procedural-steps/humira-epar-procedural-steps-taken-authorisation_en.pdf. Accessed 16 Nov 2021.

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