GP2015 as a promising therapy for rheumatoid arthritis

References

• Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016;388(10055):2023–2038.
   PubMed Web of Science ®Google Scholar
• Young A, Koduri G. Extra-articular manifestations and complications of rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2007 Oct;21(5):907–927.
   PubMed Web of Science ®Google Scholar
• Kitas GD, Gabriel SE. Cardiovascular disease in rheumatoid arthritis: state of the art and future perspectives. Ann Rheum Dis. 2011 Jan;70(1):8–14.
   PubMed Web of Science ®Google Scholar
• Doran MF, Crowson CS, Pond GR, et al. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum. 2002 Sep;46(9):2287–2293.
   PubMed Web of Science ®Google Scholar
• National Audit Office Report (HC823 2008-2009). Services for people with rheumatoid arthritis. Vol. 23, 2009 Jul, p. 1–41.
   Google Scholar
• Nam JL, Winthrop KL, van Vollenhoven RF, et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis. 2010 Jun;69(6):976–986.
   PubMed Web of Science ®Google Scholar
• Curtis JR, Singh JA. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther. 2011 Jun;33(6):679–707.
   PubMed Web of Science ®Google Scholar
• Strand V, Girolomoni G, Schiestl M, et al. The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar. Curr Med Res Opin. 2017 Jun;33(6):993–1003.
   PubMed Web of Science ®Google Scholar
• European Medicines agency. Biosimilars in the EU: Information guide for healthcare professionals. 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf.
   Google Scholar
• Kay J, Schoels MM, Dorner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis. 2018;77:165–174.
   PubMed Web of Science ®Google Scholar
• Yoo DH, Prodanovic N, Jaworski J, 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 Feb;76(2):355–363.
   PubMed Web of Science ®Google Scholar
• Emery P, Vencovsky J, Sylwestrzak A, et al. 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis. Rheumatology (Oxford). 2017 Dec 1;56(12):2093–2101.
   PubMed Web of Science ®Google Scholar
• Blair HA. GP2013: a rituximab biosimilar. BioDrugs. 2017 Oct;31(5):465–468.
   PubMed Web of Science ®Google Scholar
• Lee YJ, Shin D, Kim Y, et al. A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel(R)) in healthy subjects. Br J Clin Pharmacol. 2016 Jul;82(1):64–73.
   PubMed Web of Science ®Google Scholar
• von Richter O, Skerjanec A, Afonso M, et al. GP2015, a proposed etanercept biosimilar: pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes. Br J Clin Pharmacol. 2017 Apr;83(4):732–741.
   PubMed Web of Science ®Google Scholar
• Goffe B, Cather JC. Etanercept: an overview. J Am Acad Dermatol. 2003;49:s105–s111.
   PubMed Web of Science ®Google Scholar
• Hassett B, Singh E, Mahgoub E, et al. Manufacturing history of etanercept (Enbrel((R))): consistency of product quality through major process revisions. MAbs. 2017 Oct;11:1–7.
   Google Scholar
• Deeks ED, GP2015: an etanercept biosimilar. BioDrugs. 2017 Dec; 31(6):555–558.
   PubMed Web of Science ®Google Scholar
• Feldman M. Development of anti-TNF therapy for rheumatoid arthritis. Nat Reviews Immunol. 2002;2(5):364–371.
   PubMed Web of Science ®Google Scholar
• Dhillon S, Lyseng-Williamson KA, Scott LJ. Etanercept: a review of its use in the management of rheumatoid arthritis. Drugs. 2007;67(8):1211–1241.
   PubMed Web of Science ®Google Scholar
• Hofmann HP, Kronthaler U, Fritsch C, et al. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel((R))). Expert Opin Biol Ther. 2016 Oct;16(10):1185–1195.
   PubMed Web of Science ®Google Scholar
• Da Silva A, Kronthaler U, Fritsch C, et al. Target-directed development of a proposed biosimilar etanercept, GP2015: comparability of in vitro target binding and pre-clinical efficacy and pharmacokinetics [abstract]. Arthritis Rheumatol. 2013;65(Suppl 10).
   Google Scholar
• Campa M, Ryan C, Menter A. An overview of developing TNF-α targeted therapy for the treatment of psoriasis. Expert Opin Investig Drugs. 2015 Oct 3;24(10):1343–1354.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Guideline on the investigation of bioequivalence. Committee for Medicinal Products for Human Use (CHMP). 2010 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
   Google Scholar
• Afonso M, Sanguino Heinrich S, Poetzl J, et al. THU0145 pharmacokinetics and safety of GP2015, a proposed etanercept biosimilar, and etanercept originator product in healthy male subjects: a randomised two-way crossover study. Ann Rheum Dis. 2016;75(Suppl 2):234.
   PubMedGoogle Scholar
• Afonso M, Kollins D, Macke L, et al. THU0144 pharmacokinetics and safety of GP2015, a proposed etanercept biosimilar, administered subcutaneously by an autoinjector or prefilled syringe in healthy male subjects. Ann Rheum Dis. 2016;75(Suppl 2):233–234.
   Google Scholar
• Keffer J, Probert L, Cazlaris H, et al. Transgenic mice expressing human tumour necrosis factor: a predictive genetic model of arthritis. EMBO J. 1991 Dec;10(13):4025–4031.
   PubMed Web of Science ®Google Scholar
• Griffiths CEM, Thaci D, Gerdes S, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2017 Apr;176(4):928–938.
   PubMed Web of Science ®Google Scholar
• Kavanaugh A, Allanore Y, Kucharz E, et al. Etanercept biosimilar GP2015 has equivalent efficacy and safety to etanercept originator in patients with moderate to severe rheumatoid arthritis: the phase 3 Equira study [abstract]. Arthritis Rheumatol. 2017;69(suppl 10). [cited 2017 Nov 20]. http://acrabstracts.org/abstract/etanercept-biosimilar-gp2015-has-equivalent-efficacy-and-safety-to-etanercept-originator-in-patients-with-moderate-to-severe-rheumatoid-arthritis-the-phase-3-equira-study/
   PubMed Web of Science ®Google Scholar
• Van Der Heijde D, Hof M, Van Reil P, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Diseases. 1990;49:916–920.
   PubMed Web of Science ®Google Scholar
• Felston DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis and Rheumatism. 1995;38(6):727–735.
   PubMedGoogle Scholar
• Gerdes S, Thaci D, Griffiths C, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32(3):420-427.
   PubMedGoogle Scholar