PF-06438179/GP1111: An Infliximab Biosimilar

Author:

Al-Salama Zaina T.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference9 articles.

1. European Medicines Agency. Zessly 100 mg powder for concentrate for solution for infusion: summary of product characteristics. 2018. http://www.ema.europa.eu . Accessed 20 Sep 2018.

2. Derzi M, Johnson TR, Shoieb AM, et al. Nonclinical evaluation of PF-06438179: a potential biosimilar to Remicade® (infliximab). Adv Ther. 2016;33(11):1964–82.

3. Palaparthy R, Udata C, Hua SY, et al. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018;14(4):329–36.

4. Alten R, Tseluyko V, Hala T, et al. Efficacy, safety and immunogenicity from week 30 to week 54 in a randomised, double-blind phase III study comparing a proposed infliximab biosimilar (PF-06438179/GP1111) with reference infliximab [abstract no. FRI0137]. Ann Rheum Dis. 2018;77(Suppl 1):612.

5. Cohen SB, Alten R, Kameda H, et al. 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. Arthritis Res Ther. 2018. https://doi.org/10.1186/s13075-018-1646-4 .

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