References
- CaporaliRPallaviciniFBFilippiniMTreatment of rheumatoid arthritis with anti-TNF-alpha agents: a reappraisalAutoimmun Rev200983 274 28019017546
- SieperJPoddubnyyDNew evidence on the management of spondyloarthritisNat Rev Rheumatol2016125 282 29527052489
- KlotzUTemlASchwabMClinical pharmacokinetics and use of infliximabClin Pharmacokinet2007468 645 66017655372
- NamJLRamiroSGaujoux-VialaCEfficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritisAnn Rheum Dis2014733 516 52824399231
- MaxwellLJZochlingJBoonenASinghJAVerasMMTanjong GhogomuETNF-alpha inhibitors for ankylosing spondylitisCochrane Database Syst Rev2015 CD00546825887212
- AshZGaujoux-VialaCGossecLA systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritisAnn Rheum Dis2012713 319 32621803753
- SmolenJSLandewéRBreedveldFCEULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 updateAnn Rheum Dis2014733 492 50924161836
- SinghJASaagKGBridgesSLJr2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid ArthritisArthritis Rheumatol2016681 1 26
- BraunJvan den BergRBaraliakosX2010 Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitisAnn Rheum Dis2011706 896 90421540199
- WardMMDeodharAAklEAAmerican College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial SpondyloarthritisArthritis Rheumatol2016682 282 29826401991
- CoatesLCKavanaughAMeasePJGroup for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritisArthritis Rheumatol2016685 1060 107126749174
- GossecLSmolenJSRamiroSEuropean League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 updateAnn Rheum Dis2016753 499 51026644232
- LapadulaGFerraccioliGFBiosimilars in rheumatology: pharmacological and pharmacoeconomic issuesClin Exp Rheumatol2012304 Suppl 73 S102 S10623078880
- DranitsarisGAmirEDorwardKBiosimilars of biological drug therapies: regulatory, clinical and commercial considerationsDrugs20117112 1527 153621861538
- GoelNChanceKBiosimilars in rheumatology: understanding the rigor of their developmentRheumatology (Oxford)2017562 187 19727241704
- World Health OrganizationWHO Expert Committee on Biological Standardization. Sixty-fifth reportWorld Health Organ Tech Rep Ser2015993 1 262
- CrommelinDJAShahVPKlebovichIThe similarity question for biologicals and non-biological complex drugsEur J Pharm Sci201576 10 1725912826
- DörnerTKayJBiosimilars in rheumatology: current perspectives and lessons learntNat Rev Rheumatol20151112 713 72426282080
- AltenRCronsteinBNClinical trial development for biosimilarsSemin Arthritis Rheum201544Suppl 6 S2 S826058550
- European Medicines Agency [Internet]Guideline on similar biological medicinal products2014 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768Accessed June 14, 2017
- Food and Drug AdministrationBiosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry2009 Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM273001.pdfAccessed June 14, 2017
- GulacsiLBrodszkyVBajiPBiosimilars for the management of rheumatoid arthritis: economic considerationsExpert Rev Clin Immunol201511Suppl 1 S43 S5226395836
- JhaAUptonADunlopWCNAkehurstRThe budget impact of biosimilar infliximab (Remsima®) for the treatment of autoimmune diseases in five European CountriesAdv Ther2015328 742 75626343027
- ScheinbergMAKayJThe advent of biosimilar therapies in rheumatology – “O brave new world”Nat Rev Rheumatol201287 430 43622664834
- RogerSDMikhailABiosimilars: opportunity or cause for concern?J Pharm Pharm Sci2007103 405 41017727803
- ParkWHrycajPJekaSA 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 studyAnn Rheum Dis20137210 1605 161223687259
- YooDHHrycajPMirandaPA 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 studyAnn Rheum Dis20137210 1613 162023687260
- ChoeJ-YProdanovicNNiebrzydowskiJA 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 therapyAnn Rheum Dis2017761 58 6426318384
- LambertJWyandMLassenCBioavailability, safety and immunogenicity of biosimilar infliximab (BOW015) compared to reference infliximabInt J Clin Pharmacol Ther2016544 315 32226952037
- DerziMJohnsonTRShoiebAMNonclinical Evaluation of PF-0,64,38,179: A Potential Biosimilar to Remicade(®) (Infliximab)Adv Ther20163311 1964 198227585978
- KaurPChowVZhangNKrishnanEPharmacokinetic similarity of ABP 710 relative to infliximab: results from a randomized, single-blind, single-dose, parallel group study in healthy subjectsArthritis Rheumatol201668Suppl 10 Available from: http://acrabstracts.org/abstract/pharmacokinetic-similarity-of-abp-710-relative-to-infliximab-results-from-a-randomized-single-blind-single-dose-parallel-group-study-in-healthy-subjects/Accessed May 31, 2017
- ParkWYooDHJaworskiJComparable 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 studyArthritis Res Ther2016181 2526795209
- YooDHSuhCHShimSCA multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritisAnn Rheum Dis201776 566 57027624791
- DolinarROReillyMSBiosimilars naming, label transparency and authority of choice – survey findings among European physiciansG B I J201432 58 62
- DaneseSFiorinoGMichettiPViewpoint: Knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn’s and Colitis OrganizationJournal Crohn’s Colitis2014811 1548 1550
- Castañeda-HernándezGGonzález-RamírezRKayJScheinbergMABiosimilars in rheumatology: what the clinician should knowRMD Open201511 e00001026509046
- NjueCStatistical considerations for confirmatory clinical trials for similar biotherapeutic productsBiologicals2011395 266 26921807534
- KayJSmolenJSBiosimilars to treat inflammatory arthritis: the challenge of proving identityAnn Rheum Dis20137210 1589 159323897773
- YooDHRacewiczABrzezickiJA 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 studyArthritis Res Ther2016181 8227038608
- TakeuchiTYamanakaHTanakaYEvaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritisMod Rheumatol2015256 817 82425736355
- DeclerckPJBiosimilar monoclonal antibodies: a science-based regulatory challengeExpert Opin Biol Ther2013132 153 15623286777
- VincentFBMorandEFMurphyKMackayFMarietteXMarcelliCAntidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspectiveAnn Rheum Dis2013722 165 17823178294
- SchaeverbekeTTruchetetMEKostineMBarnetcheTBannwarthBRichezCImmunogenicity of biologic agents in rheumatoid arthritis patients: lessons for clinical practiceRheumatology (Oxford)2016552 210 22026268816
- ThomasSSBorazanNBarrosoNComparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A systematic review and meta-analysisBioDrugs2015294 241 25826280210
- BiggioggeroMDanovaMGenoveseUThe challenging definition of naïve patient for biological drug useAutoimmun Rev2015146 543 54625644102
- van SchouwenburgPAvan de StadtLAde JongRNAdalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisationAnn Rheum Dis2013721 104 10922759910
- AardenLARuulsSRWolbinkGImmunogenicity of anti-tumor necrosis factor antibodies-toward improved methods of anti-antibody measurementCurr Opin Immunol2008204 431 43518619538
- Emi AikawaNde CarvalhoJFArtur Almeida SilvaCBonfáEImmunogenicity of anti-TNF-alpha agents in autoimmune diseasesClin Rev Allergy Immunol2010382–3 82 8919565360
- KrintelSBGrunertVPHetlandMLThe frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failureRheumatology (Oxford)2013527 1245 125323459699
- PradeuTJaegerSVivierEThe speed of change: towards a discontinuity theory of immunity?Nature Publishing Group20131310 764 769
- WoodlandDLJump-starting the immune system: prime-boosting comes of ageTrends Immunol2004252 98 10415102369
- CastiglioneFMantileFDe BerardinisPPriscoAHow the interval between prime and boost injection affects the immune response in a computational model of the immune systemComput Math Methods Med20122012 84232922997539
- ParkWYooDHMirandaPEfficacy 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 studyAnn Rheum Dis2017762 346 35427117698
- Ruiz-ArgüelloMBMagureguiARuiz Del AguaAAntibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilarsAnn Rheum Dis2016759 1693 169626965981
- OlechEBiosimilars: rationale and current regulatory landscapeSemin Arthritis Rheum201645Suppl 5 S1 S10
- Food and Drug AdministrationConsiderations in Demonstrating Interchangeability with a Reference Product Guidance for Industry2017 Available from: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm537135.pdfAccessed June 14, 2017
- BraunJDeodharADijkmansBEfficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year periodArthritis Rheum2008599 1270 127818759257
- NikiphorouEKautiainenHHannonenPClinical 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 dataExpert Opin Biol Ther20151512 1677 168326549204
- GentileschiSBarrecaCBellisaiFSwitch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseasesExpert Opin Biol Ther20161610 1311 131227266338
- BenucciMGobbiFLBandinelliFSafety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational studyImmunol Res2017651 419 42227449503
- Løvik GollGOlsenICJorgensenKKBiosimilar Infliximab (CT-13) Is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway [abstract]Arthritis Rheumatol201668Suppl 10 Available from: http://acrabstracts.org/abstract/biosimilar-infliximab-ct-p13-is-not-inferior-to-originator-infliximab-results-from-a-52-week-randomized-switch-trial-in-norway/Accessed May 31, 2017
- GlintborgBSørensenIJJensenDVA Nationwide Non-Medical Switch from Originator to Biosimilar Infliximab in Patients with Inflammatory Arthritis. Eleven Months’ Clinical Outcomes from the Danbio Registry [abstract]Arthritis Rheumatol201668Suppl 10 Available from: http://acrabstracts.org/abstract/a-nationwide-non-medical-switch-from-originator-to-biosimilar-infliximab-in-patients-with-inflammatory-arthritis-eleven-months-clinical-outcomes-from-the-danbio-registry/Accessed May 31, 2017
- GlintborgBKringelbachTMHøgdallENon-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis – impact on s-infliximab and antidrug-antibodies. Results from the Danish Rheumatologic Biobank and the Danbio Registry [abstract]Arthritis Rheumatol201668Suppl 10 Available from: http://acrabstracts.org/abstract/non-medical-switch-from-originator-to-biosimilar-infliximab-in-patients-with-inflammatory-arthritis-impact-on-s-infliximab-and-antidrug-antibodies-results-from-the-danish-rheumatologic-biobank-and/Accessed May 31, 2017
- European Medicines AgencyGuideline on Similar Biological Medicinal Products2005 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdfAccessed June 14, 2017
- RoviraJEspinJGarciaLOlryAThe impact of biosimilars’ entry in the EU market [Internet]2011 [cited January 10, 2017]. Available from: http://ec.europa.eu/DocsRoom/documents/7651/attachments/1/translations/en/renditions/pdfAccessed June 14, 2017
- Italian Society of RheumatologyItalian Society of Rheumatology position paper on biosimilar [Internet]2015 [cited January 10, 2017]. Available from: http://www.reumatologia.it/obj/files/Biosimiliari/BIOSIMILARI2015.pdf
- Netherlands Medicines Evaluation BoardClarification of stance on biological and biosimilar medicines [Internet]2015 [cited January 10, 2017]. Available from: http://english.cbg-meb.nl/latest/news/2015/08/17/clarification-of-stance-on-biological-and-biosimilar-medicinesAccessed June 14, 2017