A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts-Reference-Cited by-同舟云学术

A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts

Published:2022-03-02 Issue:7 Volume:57 Page:814-824
ISSN:0036-5521
Container-title:Scandinavian Journal of Gastroenterology
language:en
Short-container-title:Scandinavian Journal of Gastroenterology

Author:

Lukas M.¹²^ORCID,Kolar M.¹^ORCID,Reissigova J.³,Duricova D.¹,Machkova N.¹,Hruba V.¹,Lukas M.¹,Vasatko M.¹,Jirsa J.¹,Pudilova K.¹,Malickova K.¹²

Affiliation:

1. IBD Clinical and Research Centre, ISCARE a.s., Prague, Czech Republic

2. First Medical Faculty, Charles University, Prague, Czech Republic

3. Institute of Computer Science of the Czech Academy of Sciences, Prague, Czech Republic

Funder

Biogen

Publisher

Informa UK Limited

Subject

Gastroenterology

Link

https://www.tandfonline.com/doi/pdf/10.1080/00365521.2022.2041082

Reference24 articles.

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2. Samsung Bioepis. Highlights of prescribing information. Hadlima (adalimumab-bwwd) injection, for subcutaneous use); 2021 [cited 2021 Jul 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf

4. European Medicines Agency. Committee for the Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products; 2020 [cited 2020 Nov 9]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf

5. US Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry; 2021 [cited 2021 Jul 20]. Available from: https://www.fda.gov/media/82647/download

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