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The FDA has approved infliximab-dyyb (Inflectra – Pfizer; marketed as Remsima in some countries), as a biosimilar of the TNF inhibitor infliximab (Remicade). Infliximab-dyyb was approved in the European Union (EU) in 2013 and in Canada in 2014. It is the second biosimilar to be approved by the FDA. Filgastrim-sndz (Zarxio), a recombinant human granulocyte colony-stimulating factor, was the first.1
BIOSIMILARS — US law defines a biosimilar as a biologic product that is highly similar to an approved biologic product (reference product) with no clinically meaningful differences in safety, purity, or potency; minor differences in clinically inactive components are allowed. An approved biosimilar product must have the same mechanism of action, route of administration, dosage form, and strength as the reference product.
- Zarxio – a filgrastim biosimilar. Med Lett Drugs Ther 2016; 58:34.
- FDA. Biosimilars Guidances. Available at: www.fda.gov. Accessed January 19, 2016.
- W Park et al. Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, phase I study. Expert Rev Clin Immunol 2015; 11 Suppl 1:S25.
- DH Yoo et al. 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. Ann Rheum Dis 2013; 72:1613.
- DH Yoo et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 2016; 18:82.
- DH Yoo et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017; 76:355.
- W Park et al. A randomised, double-blind, multicenter, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72:1605.
- W Park et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther 2016; 18:25.
- W Park et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2016; Apr 26 (epub).
- FDA Medical Review. Inflectra (infliximab-dyyb) for injection. Available at: www.accessdata.fda.gov. Accessed January 19, 2017.
- J Jahnsen. Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients. Therap Adv Gastroenterol 2016; 9:322.
- KK Jorgensen et al. Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from the 52-week randomized NOR-SWITCH trial. UEG Journal 2016; 4(6):805. Abstract LB15. Available at: http://journals.sagepub.com. Accessed January 19, 2017.