A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®)

Author:

Kim Soohyun,Kim Siun,Lee HowardORCID

Publisher

Informa UK Limited

Subject

Drug Discovery,Pharmaceutical Science,Pharmacology

Reference22 articles.

1. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

2. Celltrion. CT-P13 briefing document for the arthritis advisory committee. [updated February 9, 2016; cited Feb, 2016]. Available from: https://www.fda.gov/media/95998/download.

3. Food and Drug Administration. Statistical review of BLA125544. [cited Oct, 2015]. Available from: www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000StatR.pdf. Accessed May 7, 2020.

4. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

5. Food and Drug Administration. Biosimilar multi-disciplinary evaluation and review: BLA 761086 ABP 710, a proposed biosimilar to U.S.-licensed remicade (infliximab). [cited Dec, 2018]. Available from: https://www.fda.gov/media/134460/download. Accessed May 7, 2020.

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