Infliximab biosimilar GP1111: a review of 5 years’ post-approval experience-Reference-Cited by-同舟云学术

Infliximab biosimilar GP1111: a review of 5 years’ post-approval experience

Published:2024-07-02 Issue:7 Volume:24 Page:615-625
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Huizinga Thomas W. J.¹,Dipasquale Valeria²,Zabransky Markus³,Heyn Jens⁴,Romano Claudio²

Affiliation:

1. Department of Rheumatology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands

2. Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood “G. Barresi”, “G. Martino” University Hospital, University of Messina, Messina, Italy

3. Global Medical Affairs, Sandoz/HEXAL AG, Holzkirchen, Germany

4. Global Clinical Development, Sandoz/HEXAL AG, Holzkirchen, Germany

Funder

Sandoz Group AG

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2024.2377298

Reference58 articles.

1. Remicade summary of product characteristics [Internet]. European Medicines Agency. 2022 [updated 2022 Sep 26

2. cited 2022 Nov 16]. Available from: https://www.ema.europa.eu/en/documents/product-information/remicade-epar-product-information_en.pdf

3. REMICADE highlights of prescribing information [Internet]. US Food and Drug Administration. 2020 [cited 2023 Nov 16]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf

4. The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product

5. Infliximab Approved for Use in Crohnʼs Disease: A Report on the FDA GI Advisory Committee Conference