The safety of emerging biosimilar drugs for the treatment of rheumatoid arthritis

References

• Cross M, Smith E, Hoy D, et al. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73:1316–1322.
   PubMed Web of Science ®Google Scholar
• Gonzalez A, Maradit Kremers H, Crowson CS, et al. The widening mortality gap between rheumatoid arthritis patients and the general population. Arthritis Rheum. 2007;56:3583–3587.
   PubMed Web of Science ®Google Scholar
• Gulacsi L, Brodszky V, Baji P, et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol. 2015;11(suppl 1):S43–S52.
   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;33:679–707.
   PubMed Web of Science ®Google Scholar
• Singh JA, Christensen R, Wells GA, et al. Biologics for rheumatoid arthritis: an overview of Cochrane reviews. Cochrane Database Syst Rev. 2009. DOI:10.1002/14651858.CD007848.pub2
   Web of Science ®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;69:976–986.
   PubMed Web of Science ®Google Scholar
• Listing J, Kekow J, Manger B, et al. Mortality in rheumatoid arthritis: the impact of disease activity, treatment with glucocorticoids, TNFalpha inhibitors and rituximab. Ann Rheum Dis. 2015;74:415–421.
   PubMed Web of Science ®Google Scholar
• Putrik P, Ramiro S, Kvien TK, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014;73:198–206.
   PubMed Web of Science ®Google Scholar
• Modena V, Bianchi G, Roccatello D. Cost-effectiveness of biologic treatment for rheumatoid arthritis in clinical practice: an achievable target? Autoimmun Rev. 2013;12:835–838.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues 2012; [cited 2016 Sep 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
   Google Scholar
• US Food and Drug Administration. 2015. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry; [cited 2016 Sep 26]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf
   Google Scholar
• Reinisch W, Smolen J. Biosimilar safety factors in clinical practice. Sem Arthritis Rheum. 2015;44:S9–S15.
   PubMed Web of Science ®Google Scholar
• Castañeda-Hernández G, González-Ramírez R, Kay J, et al. Biosimilars in rheumatology: what the clinician should know. RMD Open. 2015;1:e000010.
   PubMed Web of Science ®Google Scholar
• Central Drugs Standard Control Organization. 2016. Guidelines on similar biologic: regulatory requirements for marketing authorization in India; [cited 2016 Sep 26]. Available from: http://www.cdsco.nic.in/writereaddata/Proposed%20Guidelines%20for%20Similar%20Biologic%202016.pdf
   Google Scholar
• European Medicines Agency. 2014. Summary of product characteristics: MabThera concentrate for solution for infusion; [cited 2016 September 26]. Available from: https://www.medicines.org.uk/emc/medicine/2570
   Google Scholar
• Generics and Biosimilars Initiative. 2015. Biosimilars in emerging markets; [cited 2016 Sep 26]. Available from: http://gabi-journal.net/news/biosimilars-in-emerging-markets
   Google Scholar
• International Conference on Harmonisation. 2004. Comparability of biotechnological/biological products subject to changes in their manufacturing process; [cited 2016 December 07] Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html
   Google Scholar
• European Medicines Agency. 2014. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues; [cited 2016 September 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf
   Google Scholar
• Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295:2275–2285.
   PubMed Web of Science ®Google Scholar
• Leombruno JP, Einarson TR, Keystone EC. The safety of anti-tumour necrosis factor treatments in rheumatoid arthritis: meta and exposure-adjusted pooled analyses of serious adverse events. Ann Rheum Dis. 2009;68:1136–1145.
   PubMed Web of Science ®Google Scholar
• Salliot C, Dougados M, Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials. Ann Rheum Dis. 2009;68:25–32.
   PubMed Web of Science ®Google Scholar
• Thompson AE, Rieder SW, Pope JE. Tumor necrosis factor therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum. 2011;63:1479–1485.
   PubMed Web of Science ®Google Scholar
• Singh JA, Cameron C, Noorbaloochi S, et al. Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet. 2015;386:258–265.
   PubMed Web of Science ®Google Scholar
• Dixon WG, Hyrich KL, Watson KD, et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis. 2010;69:522–528.
   PubMed Web of Science ®Google Scholar
• Gomez-Reino JJ, Carmona L, Valverde VR, et al. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum. 2003;48:2122–2127.
   PubMed Web of Science ®Google Scholar
• Ding T, Ledingham J, Luqmani R, et al. BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies. Rheumatology (Oxford). 2010;49:2217–2219.
   PubMed Web of Science ®Google Scholar
• Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2012. Ann Rheum Dis. 2013;72(suppl 2):ii2–34.
   PubMed Web of Science ®Google Scholar
• Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64:625–639.
   PubMed Web of Science ®Google Scholar
• Cantini F, Boccia S, Goletti D, et al. HBV reactivation in patients treated with antitumor necrosis factor-alpha (TNF-alpha) agents for rheumatic and dermatologic conditions: a systematic review and meta-analysis. Int J Rheumatol. 2014;2014:926836.
   PubMedGoogle Scholar
• Souto A, Maneiro JR, Salgado E, et al. Risk of tuberculosis in patients with chronic immune-mediated inflammatory diseases treated with biologics and tofacitinib: a systematic review and meta-analysis of randomized controlled trials and long-term extension studies. Rheumatology. 2014;53:1872–1885.
   PubMed Web of Science ®Google Scholar
• Van Vollenhoven RF, Fleischmann RM, Furst DE, et al. Longterm safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol. 2015;42:1761–1766.
   PubMed Web of Science ®Google Scholar
• Rituxan® (rituximab) prescribing information.; [cited 2016 Sep 26]. Available from: http://www.gene.com/download/pdf/rituxan_prescribing.pdf
   Google Scholar
• Dreyer L, Mellemkjaer L, Andersen AR, et al. Incidences of overall and site specific cancers in TNFalpha inhibitor treated patients with rheumatoid arthritis and other arthritides - a follow-up study from the DANBIO registry. Ann Rheum Dis. 2013;72:79–82.
   PubMed Web of Science ®Google Scholar
• Mariette X, Matucci-Cerinic M, Pavelka K, et al. Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis. Ann Rheum Dis. 2011;70:1895–1904.
   PubMed Web of Science ®Google Scholar
• Strangfeld A, Hierse F, Rau R, et al. Risk of incident or recurrent malignancies among patients with rheumatoid arthritis exposed to biologic therapy in the German biologics register RABBIT. Arthritis Res Ther. 2010;12:R5.
   PubMed Web of Science ®Google Scholar
• Mercer LK, Lunt M, Low AL, et al. Risk of solid cancer in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register for rheumatoid arthritis. Ann Rheum Dis. 2015;74:1087–1093.
   PubMed Web of Science ®Google Scholar
• Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA, et al. Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis. JAMA. 2012;308:898–908.
   PubMed Web of Science ®Google Scholar
• Raaschou P, Simard JF, Holmqvist M, et al. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma: nationwide population based prospective cohort study from Sweden. BMJ. 2013;346:f1939.
   PubMed Web of Science ®Google Scholar
• Hellgren K, Dreyer L, Arkema EV, et al. Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: a collaborative study from the ARTIS and DANBIO registers. Ann Rheum Dis. 2016. Published online 2016 May 4. DOI:10.1136/annrheumdis-2016-209270
   Web of Science ®Google Scholar
• Michelsen B, Fiane R, Diamantopoulos AP, et al. A comparison of disease burden in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. Plos One. 2015;10:e0123582.
   PubMed Web of Science ®Google Scholar
• Baecklund E, Iliadou A, Askling J, et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthritis Rheum. 2006;54:692–701.
   PubMed Web of Science ®Google Scholar
• Brown SL, Greene MH, Gershon SK, et al. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002;46:3151–3158.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492–509.
   PubMed Web of Science ®Google Scholar
• Thomas SS, Borazan N, Barroso N, et al. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A systematic review and meta-analysis. BioDrugs. 2015;29:241–258.
   PubMed Web of Science ®Google Scholar
• Felis-Giemza A, Moots RJ. Measurement of anti-drug antibodies to biologic drugs. Rheumatology (Oxford). 2015;54:1941–1943.
   PubMed Web of Science ®Google Scholar
• Pascual-Salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford). 2011;50:1445–1452.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. 2016. Assay development and validation for immunogenicity testing of therapeutic protein products. Guidance for industry; [cited 2016 Sep 26]. Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/UCM192750.pdf
   Google Scholar
• European Medicines Agency. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (draft). 2015; [cited 2016 Aug 26]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500194507.pdf.
   Google Scholar
• Kim JS, Kim SH, Kwon B, et al. Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13). Expert Rev Clin Immunol. 2015;11:33–41.
   PubMed Web of Science ®Google Scholar
• Braun J, Baraliakos X, Kudrin A, et al. Striking discrepancy in the development of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in response to infliximab (INF) and its biosimilar CT-P13. Arthritis Rheumatol. 2014;66(suppl 10):Abstract L21.
   Google Scholar
• Collamer AN, Guerrero KT, Henning JS, et al. Psoriatic skin lesions induced by tumor necrosis factor antagonist therapy: a literature review and potential mechanisms of action. Arthritis Care Res (Hoboken). 2008;59:996–1001.
   Web of Science ®Google Scholar
• Wendling D, Paccou J, Berthelot JM, et al. New onset of uveitis during anti-tumor necrosis factor treatment for rheumatic diseases. Sem Arthritis Rheum. 2011;41:503–510.
   PubMed Web of Science ®Google Scholar
• Toussirot E, Houvenagel E, Goeb V, et al. Development of inflammatory bowel disease during anti-TNF-alpha therapy for inflammatory rheumatic disease: a nationwide series. Joint Bone Spine. 2012;79:457–463.
   PubMed Web of Science ®Google Scholar
• European Commission, Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products. 2013: European Commission.
   Google Scholar
• Weise M, Bielsky M-C, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111–5117.
   PubMed Web of Science ®Google Scholar
• Paul-Ehrlich-Institut. Position of Paul-Ehrlich-Institut regarding the use of biosimilars. 2015; [cited 2016 Sep 29]. Available from: http://www.pei.de/EN/medicinal-products/antibodies-immunoglobulins-fusion-proteins/monoclonal-antibodies/biosimilars/position-pei-interchangebility-biosimilars-content.html
   Google Scholar
• Biologics Price Competition and Innovation Act of 2009. 2009; [cited 2016 Sep 26]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf
   Google Scholar
• European Medicines Agency. 2013. Assessment report: Remsima; [cited 2016 Sep 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf
   Google Scholar
• US Food and Drug Administration. Inflectra (infliximab-dyyb) prescribing information; [cited 2016 Sep 26]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
   Google Scholar
• Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, 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;72:1605–1612.
   PubMed Web of Science ®Google Scholar
• Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. MAbs. 2014;6:1163–1177.
   PubMed Web of Science ®Google Scholar
• Park W, Yoo DH, Jaworski J, 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.
   PubMed Web of Science ®Google Scholar
• Yoo DH, Racewicz A, Brzezicki J, 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.
   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. 2016. Published online 2016 April 29. DOI:10.1136/annrheumdis-2015-208786
   Web of Science ®Google Scholar
• Takeuchi T, Yamanaka H, Tanaka Y, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2015;25:817–824.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Yamanaka H, Takeuchi T, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol. 2016. Published online 2016 Sep 3. DOI:10.1080/14397595.2016.1206244
   Google Scholar
• Choe JY, Prodanovic N, Niebrzydowski J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2015. Published online 2015 Aug 28. DOI:10.1136/annrheumdis-2015-207764
   Web of Science ®Google Scholar
• Kay J, Wyand M, Chandrashekara S, et al. A phase 3, randomized, double-blind, active comparator study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis on stable methotrexate doses. Ann Rheum Dis 2014;73:64;OP0012.
   Google Scholar
• CELLTRION Inc. 2016. CT-P13 (infliximab biosimilar) briefing document for the Arthritis Advisory Committee; [cited 2016 Sep 26]. Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm484860.pdf
   Google Scholar
• Ruiz-Arguello MB, Maguregui A, Ruiz Del Agua A, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis. 2016;75:1693–1696.
   PubMed Web of Science ®Google Scholar
• Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2016;65:1132–1138.
   PubMed Web of Science ®Google Scholar
• Sung YK, Cho SK, Won S, et al. Characteristics and outcomes of RA patients who start biosimilar infliximab in South Korea. Arthritis Rheumatol. 2015;67(suppl 10):Abstract 1221.
   Google Scholar
• Nikiphorou E, Kautiainen H, Hannonen P, et al. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677–1683.
   PubMed Web of Science ®Google Scholar
• Holroyd C, Parker L, Bennett S, et al. Switching to biosimilar infliximab: real-world data from the Southampton Biologic Therapies Review service. Rheumatology. 2016;55(suppl 1):i60–1.
   Google Scholar
• Shin D, Kim Y, Kim YS, et al. A randomized, phase I pharmacokinetic study comparing SB2 and infliximab reference product (Remicade®) in healthy subjects. BioDrugs. 2015;29:381–388.
   PubMed Web of Science ®Google Scholar
• Choe JY, Prodanovic N, Niebrzydowski J, et al. A randomized, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product (Remicade®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy: 54-week results. Arthritis Rheumatol. 2015;67(suppl 10):Abstract 2056.
   Google Scholar
• Smolen JS, Choe JY, Prodanovic N, et al. Comparable safety and immunogenicity and sustained efficacy after transition to SB2 (an infliximab biosimilar) vs ongoing reference infliximab (Remicade®) in patients with rheumatoid arthritis: results of phase III transition study. Arthritis Rheumatol. 2016;68(suppl 10):Abstract 2596.
   Google Scholar
• Kay J, Wyand M, Chandrashekara S, et al. BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis on stable methotrexate doses: 54-week results of a randomized, double-blind, active comparator study. Arthritis Rheumatol. 2014;66(suppl 10):Abstract L20.
   Google Scholar
• Cho IH, Lee N, Song D, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. MAbs. 2016;8:1136–1155.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. 2015. Assessment report:Benepali. [cited 2016 Sep 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004007/WC500200380.pdf
   Google Scholar
• Emery P, Vencovsky J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2015. Published online 2015 July 6. DOI:10.1136/annrheumdis-2015-207588
   Web of Science ®Google Scholar
• Emery P, Vencovský J, Ghil J, et al. Difference between SB4 and reference etanercept in the hepatobiliary disorders not considered to be caused by SB4: response to letter by Scheinberg and Azevedo. Ann Rheum Dis. 2016;75:e65.
   PubMed Web of Science ®Google Scholar
• Emery P, Breedveld FC, Hall S, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008;372:375–382.
   PubMed Web of Science ®Google Scholar
• Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002;46:1443–1450.
   PubMed Web of Science ®Google Scholar
• Vencovsky J, Sylwestrzak A, Leszczyñski P, et al. A phase III, randomized, double-blind clinical study comparing SB4, an etanercept biosimilar, with etanercept reference product (Enbrel®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (52-week results). Arthritis Rheumatol. 2015;67(suppl 10):Abstract 2055.
   Google Scholar
• Emery P, Vencovský J, Sylwestrzak A, et al. Long-term safety and efficacy of SB4 (etanercept biosimilar) in patients with rheumatoid arthritis: comparison between continuing SB4 and switching from etanercept reference product to SB4. Ann Rheum Dis. 2016;75:236.
   Google Scholar
• Sandoz Inc. 2016. Arthritis Advisory Committee briefing document. GP2015 (proposed INN: etanercept) biosimilar; [cited 2016 Sep 26]. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510494.pdf.
   Google Scholar
• Amgen Inc. 2016. Arthritis Advisory Committee Meeting Briefing Document. ABP 501, a proposed biosimilar to Humira; [cited 2016 Sep 26]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510295.pdf
   Google Scholar
• Cohen S, Pablos JL, Zhang N, et al. ABP 501 long-term safety/efficacy: interim results from an open-label extension study. Arthritis Rheumatol. 2016;68(suppl 10):Abstract 616.
   Google Scholar
• Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. A phase III, randomized, double-blind clinical study comparing SB5, an adalimumab biosimilar, with adalimumab reference product (Humira®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (24-week results). Arthritis Rheumatol. 2015;67(suppl 10):Abstract 8L.
   Google Scholar
• Jani RH, Gupta R, Bhatia G, et al. A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis. 2015. Published online 2015 July 14. DOI:10.1111/1756-185x.12711
   PubMed Web of Science ®Google Scholar
• Weinblatt M, Baranauskaite A, Niebrzydowski J, et al. Sustained efficacy and comparable safety and immunogenicity after transition to SB5 (an adalimumab biosimilar) vs. continuation of SB5 or reference adalimumab (Humira®) in patients with rheumatoid arthritis: results of phase III study. Arthritis Rheumatol. 2016;68(suppl 10):5.
   Google Scholar
• Yoo DH, Suh CH, Shim SC, et al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016. Published online 2016 Sep 13. DOI:10.1136/annrheumdis-2016-209540
   Google Scholar
• Yoo D, Park W, Suh C, et al. Efficacy and safety of rituximab biosimilar candidate (CT-P10) and innovator rituximab in patients with rheumatoid arthritis: results from phase I randomized controlled trial over 72 weeks. Arthritis Rheumatol. 2015;67(suppl 10):Abstract 2058.
   Google Scholar
• Yoo D, Park W, Suh C, et al. Efficacy and safety of switched CT-P10 from innovator rituximab compared to those of maintained CT-P10 in patients with rheumatoid arthritis up to 56 weeks. Arthritis Rheumatol. 2015;67(suppl 10):Abstract 1675.
   Google Scholar
• Smolen J, Scheinberg M, Tony H-P, et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-approved rituximab (RTX) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. Ann Rheum Dis. 2016;75(suppl 2):512.
   Google Scholar
• Cohen S, Emery P, Greenwald M, et al. A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis. Br J Clin Pharmacol. 2016;82:129–138.
   PubMed Web of Science ®Google Scholar
• Kaplanov K, Zaritskiy A, Alexeev S, et al. Key results of international randomized open-label clinical study of BCD-020 (rituximab biosimilar candidate) in patients with B-cell non-Hodgkin’s lymphoma. Blood. 2014;124:5467–5467.
   Web of Science ®Google Scholar
• Eremeeva A, Chernyaeva E, Ivanov R, et al. Comparison of efficacy and safety of rituximab biosimilar, BCD-020, and innovator rituximab in patients with active rheumatoid arthritis refractory to TNFa inhibitors. Ann Rheum Dis. 2016;75(suppl 2):513.
   Google Scholar
• Nasonov E, Mazurov V, Plaksina T, et al. Interchangeability of innovator rituximab and its biosimilar: results from international controlled comparative 1-year study in patients with active rheumatoid arthritis. Arthritis Rheumatol. 2016;68(suppl 10):Abstract 1639.
   Google Scholar
• Ben-Horin S, Vande Casteele N, Schreiber S, et al. Biosimilars in inflammatory bowel disease: facts and fears of extrapolation. Clin Gastroenterol Hepatol. 2016;14:1685–1696.
   PubMed Web of Science ®Google Scholar
• Health Canada. 2014. Summary Basis of Decision (SBD) for Remsima; [cited 2016 Sep 26]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_remsima_160195-eng.php
   Google Scholar
• Health Canada. 2016. Regulatory decision summary INFLECTRA; [cited 2016 Sep 26]. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sdr-infectra-184564-eng.php
   Google Scholar
• Farkas K, Rutka M, Balint A, et al. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis - experiences from a single center. Expert Opin Biol Ther. 2015;15:1257–1262.
   PubMed Web of Science ®Google Scholar
• Gecse KB, Lovasz BD, Farkas K, et al. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J Crohns Colitis. 2016;10:133–140.
   PubMed Web of Science ®Google Scholar
• Jahnsen J, Detlie TE, Vatn S, et al. Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study. Expert Rev Gastroenterol Hepatol. 2015;9(suppl 1):45–52.
   PubMedGoogle Scholar
• Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30:1705–1712.
   PubMed Web of Science ®Google Scholar
• Kang YS, Moon HH, Lee SE, et al. Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci. 2015;60:951–956.
   PubMed Web of Science ®Google Scholar
• Park SH, Kim YH, Lee JH, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol. 2015;9(suppl 1):35–44.
   PubMedGoogle Scholar
• Sieczkowska J, Jarzebicka D, Banaszkiewicz A, et al. Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10:127–132.
   PubMed Web of Science ®Google Scholar
• Keil R, Wasserbaeur M, Zádorvá Z, et al. Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis. Scand J Gastroenterol. 2016;51:1062–1068.
   PubMed Web of Science ®Google Scholar
• Fiorino G, Manetti N, Variola A, et al. Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD. J Crohns Colitis 2016;10(suppl 1):S376-S377;P544.
   Google Scholar
• Murphy C, Sugrue K, Mohamad G, et al. Biosimilar but not the same. J Crohns Colitis 2015;9(Suppl 1):S331-S332;P505.
   Google Scholar
• Reinisch W, Louis E, Danese S. The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13. Expert Rev Gastroenterol Hepatol. 2015;9:17–26.
   PubMedGoogle Scholar
• Goll GL, Olsen IC, Jorgensen KK, et al. Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from a 52-week randomized switch trial in Norway. Arthritis Rheumatol. 2016;68(suppl 10):19L.
   Google Scholar