SAGES Magazine

WHAT’S BEHIND AMGEVITA™ MAKES THE DIFFERENCE A company that has served patients with chronic inflammatory conditions for over 20 years 1 and a proven leader with four decades of experience in biologics 2,3 S4 AMGEVITA 40 mg solution for injection in pre-filled syringe. Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 ml (50 mg/ml) solution. Reg. No. 51/30.1/0678. S4 AMGEVITA 40 mg solution for injection in pre-filled pen. Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 ml (50 mg/ml) solution. Reg. No. 51/30.1/0678. For full prescribing information refer to the package insert approved by the medicines regulatory authority. Amgen South Africa (Pty) Ltd., Co. Reg. No.: 2011/112148/07. Building D, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston Ext. 7, 2021. Tel: 011 100 5300 Fax: 011 100 5301. Adverse Event Reporting email safety-south-africa@amgen.com. Medical information email: medinfo-mea@amgen.com. PR-AMV-ZAF-000014-05-2021. References: 1. AMGEN Therapeutic Area Heritage. C2019. Accessed 20/4/2021. Available from https://www.amgenbiosimilars.com/heritage/therapeutic-area-heritage/ 2. AMGEN Fact Sheet. C2020. Accessed 20/4/2021. Available from https://www.amgen.com/about/quick-facts/ 3. AMGEN Biotech. C2017. Accessed 20/4/2021. Available from https://www. amgenbiotech.com/manufacturing-innovation.html 4. Markus R, McBride HJ, Ramchandani M, et al. A review of the totality of evidence supporting the development of the first adalimumab biosimilar ABP 501. Adv Ther 2019;36:1833-1850. 5. AMGEVITA™ package insert. 18 Feb 2020. 6. Liu J, Eris T, Li C, et al. Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab. BioDrugs 2016;30:321-338. 7. Velayudhan J, Chen Y-F, Rohrbach A, et al. Demonstration of functional similarity of proposed biosimilar ABP 501 to adalimumab. BioDrugs 2016:30:339-351. 8. Amgen Inc. Background Information for AAC. 12 July 2016. 9. Kaur P, Chow V, Zhang N, et al. A randomised, single-blind, single-dose, three- arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis 2017;76:526-533. 10. 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 lll equivalence study. Ann Rheum Dis 2017;76:1679-1687. 11. Macaluso FS, Cappello M, Busacca A, et al. A Sicilian prospective observational study of patients with inflammatory bowel disease treated with adalimumab biosimilar ABP 501. Poster presented at UEGW 2020. P0614. 12. Ribaldone DG, Caviglia GP, Pellicano R, et al. Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn’s disease: an observational study. Rev Esp Enferm Dig 2020;112(3):195-200. 13. Becciolini A, Caccavale R, Parisi S, et al. Retention rate of adalimumab and ABD 501 in the treatment of a large cohort of patients with inflammatory arthritis: A real-life retrospective analysis. Abstract FRI0085. 2020. Available at: https://ard.bmj.com/content/79/ Suppl_1/620.1 14. Cuomo G. [Adalimumab biosimilare nella real life: casistica monocentrica di pazienti con artrite psoriasica. Valutazione a tre mesi]. Intern Emerg Med 2019;NS1:NS2-NS4. 15. De Simone C, Caldarola G, Pirro F, et al. [Adalimumab biosimilare nella psoriasis: esperienza clinica nei pazienti naïve e post-switch da altre molecole. Intern Emerg Med 2019;NS1:NS4- NS6. Is approved across all key adalimumab indications 5 Demonstrates bioequivalence and biosimilarity to the originator 6,7,8,9,10 Supported by safety and effectiveness data from ongoing real-world studies 11,12,13,14,15 adalimumab biosimilar 4a Amgevita™