References
- Humira Prescribing information. Available from: https://www.rxabbvie.com/pdf/humira.pdf [cited 2021 Dec]
- Humira. Summary of product characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_en.pdf [cited 2021 Dec]
- Nash P, Vanhoof J, Hall S, et al. Randomized crossover comparison of injection site pain with 40 mg/0.4 or 0.8 mL formulations of Adalimumab in patients with rheumatoid arthritis. Rheumatol Ther. 2016;3(2):257–270.
- Park SH, Park JC, Lukas M, et al. Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases. Intest Res. 2020;18(1):34–44.
- Smolen JS, Goncalves J, Quinn M, et al. Era of biosimilars in rheumatology: reshaping the healthcare environment. RMD Open. 2019;5:e000900.
- Jacobs P, Bissonnette R, Guenther LC. Socioeconomic burden of immune-mediated inflammatory diseases–focusing on work productivity and disability. J Rheumatol Suppl. 2011;88:55–61.
- Scientific considerations in demonstrating biosimilarity to a reference product. U.S. Food and Drug Administration (FDA). Available from: https://www.fda.gov/media/82647/download#:~:text=To%20demonstrate%20biosimilarity%2C%20a%20sponsor,between%20the%20two%20products%20in.
- Guideline on similar biological medicinal products. European Medicines Agency (EMA). Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf.
- Guidelines on evaluation of similar biotherapeutic products (SBPs). World Health Organization (WHO). Available from: https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
- Biosimilar Product Information (FDA). Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.
- https://www.ema.europa.eu/en/medicines(EMA).
- Bergman M, Patel P, Chen N, et al. Evaluation of adherence and persistence differences between adalimumab citrate-free and citrate formulations for patients with immune-mediated diseases in the United States. Rheumatol Ther. 2021;8(1):109–118.
- Alvotech 2021. Available from: https://www.alvotech.com/newsroom/avt02-approved-for-use-in-european-union
- Basic principles on Global Clinical Trials (PMDA). Available from: https://www.pmda.go.jp/files/000157900.pdf
- Bioanalytical Method Validation Guidance for Industry. May 2018. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Center for Veterinary Medicine (CVM).
- Guideline on bioanalytical method validation. 21 July 2011. European medicines agency. Committee for medicinal products for human use (CHMP) EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2
- Marini JC, Anderson M, Cai XY, et al. Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments. AAPS J. 2014;16(6):1149–1158.
- Civoli F, Kasinath A, Cai XY, et al. Recommendations for the development and validation of immunogenicity assays in support of biosimilar programs. AAPS J. 2019;22(1):7.
- Immunogenicity testing of therapeutic protein products —developing and validating assays for anti-drug antibody detection. U.S. Food and Drug Administration (FDA). Available from: https://www.fda.gov/media/119788/download
- Guideline on immunogenicity assessment of therapeutic proteins. European Medicines Agency (EMA). Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf
- Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994;50(4):1029–1041.
- Jennison C, Turnbull BW. Interim analyses: the repeated confidence interval approach. J R Stat Soc Series B Stat Methodol. 1989;51(3):305–361.
- Agresti A, Min Y. On small-sample confidence intervals for parameters in discrete distributions. Biometrics. 2001;57:963–971.
- Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15(6):657–680.
- McClellan JE, Conlon HD, Bolt MW, et al. The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product. Therap Adv Gastroenterol. 2019 Jun 13;12:1756284819852535.
- Shankar G, Arkin S, Cocea L, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014;16(4):658–673.
- Wynne C, Altendorfer M, Sonderegger I, et al. Bioequivalence, safety and immunogenicity of BI 695501, an Adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects. Expert Opin Investig Drugs. 2016;25(12):1361–1370.
- Shin D, Lee Y, Kim H, et al. A randomized phase I comparative pharmacokinetic study comparing SB5 with reference Adalimumab in healthy volunteers. J Clin Pharm Ther. 2017;42(6):672–678.
- Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of Adalimumab therapy in Crohn’s disease. Gastroenterology. 2009;137(5):1628–1640.
- Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Anti-infliximab and anti-Adalimumab antibodies in relation to response to Adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis. 2010;69(5):817–821.
- Menter A, Tyring SK, Gordon K, Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106–115.
- Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial. Gut. 2007;56(9):1232–1239.
- Bender NK, Heilig CE, Dröll B, et al. Immunogenicity, efficacy and adverse events of Adalimumab in RA patients. Rheumatol Int. 2007;27(3):269–274.
- van de Putte LB, Atkins C, Malaise M, et al. Efficacy and safety of Adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis. 2004;63(5):508–516.
- Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against Adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011;305(14):1460–1468.
- de Vries MK, Brouwer E, van der Horst-bruinsma IE, et al. Decreased clinical response to Adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis. 2009;68(11):1787–1788.
- Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to Adalimumab: relationship to anti-Adalimumab antibodies and serum Adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007;66(7):921–926.
- Yu KS, Jang IJ, Lim HS, et al. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference Adalimumab: a randomized phase I study in healthy subjects. Clin Transl Sci. 2021;14(4):1280–1291.
- Feldman SR, Reznichenko N, Pulka G, et al. Efficacy, safety and immunogenicity of AVT02 versus originator Adalimumab in subjects with moderate to severe chronic Plaque Psoriasis: a multicentre, double-blind, randomised, parallel group, active control, Phase III study. BioDrugs. 2021;35(6):735–748.
- Von Richter O, Lemke L, Haliduola H, et al. GP2017, an Adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods. Expert Opin Biol Ther. 2019;19(10):1075–1083.
- Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Similar efficacy, safety and immunogenicity of Adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018;77:914–921.
- Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of the biosimilar ABP 501 compared with Adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017;177(6):1562–1574.
- Cohen S, Genovese MC, Choy E, et al. Efficacy and safety of the biosimilar ABP 501 compared with Adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017;76(10):1679–1687.