A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501-Reference-Cited by-同舟云学术

A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501

Published:2019-06-10 Issue:8 Volume:36 Page:1833-1850
ISSN:0741-238X
Container-title:Advances in Therapy
language:en
Short-container-title:Adv Ther

Author:

Markus Richard,McBride Helen J.,Ramchandani Monica,Chow Vincent,Liu Jennifer,Mytych Dan,Fanjiang Gary

Funder

Amgen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),General Medicine

Link

http://link.springer.com/content/pdf/10.1007/s12325-019-00979-6.pdf

Reference25 articles.

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2. Horiuchi T, Mitoma H, Harashima S, Tsukamoto H, Shimoda T. Transmembrane TNF-alpha: structure, function and interaction with anti-TNF agents. Rheumatology. 2010;49(7):1215–28 (Oxford).

3. AMJEVITA (adalimumab-atto) injection for subcutaneous use [prescribing information]. Thousand Oaks, CA: Amgen Inc, 2016.

4. AMGEVITA (adalimumab) injection for subcutaneous use [summary of product characteristics]. Breda, The Netherlands: Amgen Europe, 2017.

5. Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf . Accessed 3 Aug 2018.

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