A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence-Reference-Cited by-同舟云学术

A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence

Published:2021-07-27 Issue: Volume: Page:
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Macaluso Fabio Salvatore¹,Cummings JR Fraser²^ORCID,Atreya Raja³,Choi Jaeyun⁴,Orlando Ambrogio¹

Affiliation:

1. Gastroenterologist, Inflammatory Bowel Disease Unit, “Villa Sofia-Cervello” Hospital, Strasburgo 233, 90146 Palermo, Italy

2. Gastroenterologist, Department of Gastroenterology, University Hospital Southampton, and University of Southampton, Tremona Road, Southampton, Hampshire SO16 6YD, UK

3. Gastroenterologist, Department of Medicine, Medical Clinic 1, University Hospital Erlangen, University of Erlangen-Nürnberg Erlangen, Ulmenweg 18, 91054 Erlangen, Germany

4. Manager Medical Affairs Group, Samsung Bioepis, 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, Republic of Korea

Funder

Samsung Bioepis Co., Ltd

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2021.1958778

Reference42 articles.

1. References

2. 1. Janssen Biologics. Remicade - Summary of Product Characteristics. 1999.

3. 2. Janssen Biotech. Remicade - Prescribing Information. 1998.

4. 3. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 2015 [March 24, 2020]. Available from: https://www.fda.gov/media/82647/download

5. 4. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues 2012 [March 24, 2020]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf

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