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

Annals of the Rheumatic Diseases

Volumn 76, Issue 10, 2017, Pages 1679-1687

  Cohen, Stanley ^a   Genovese, Mark C ^b   Choy, Ernest ^c   Perez Ruiz, Fernando ^d   Matsumoto, Alan ^e   Pavelka, Karel ^f   Pablos, Jose L ^g   Rizzo, Warren ^h   Hrycaj, Pawel ⁱ   Zhang, Nan ^j   Shergy, William ^k   Kaur, Primal ^j  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CARDIFF UNIVERSITY   (United Kingdom)

^d BIOCRUCES BIZKAIA HEALTH RESEARCH INSTITUTE   (Spain)

^e Arthritis and Rheumatism Associates   (United States)

^f Na Slupi 4 Praha 2   (Czech Republic)

^g UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^h Advanced Arthritis Care and Research   (United States)

ⁱ POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^j AMGEN INC   (United States)

^k RANA Clinical Research Center   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; C REACTIVE PROTEIN; DRUG ANTIBODY; METHOTREXATE; ANTIBODY; ANTIRHEUMATIC AGENT;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DAS28; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; FEMALE; HEART FAILURE; HEMATOLOGIC DISEASE; HUMAN; HYPERTRANSAMINASEMIA; IMMUNOGENICITY; INFECTION; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASM; PHARMACEUTICAL EQUIVALENCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; TREATMENT DURATION; ARTHRITIS, RHEUMATOID; BLOOD; CLINICAL TRIAL; METABOLISM; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCE; VERY ELDERLY; YOUNG ADULT;

ADALIMUMAB; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; C-REACTIVE PROTEIN; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 85024905533     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2016-210459     Document Type: Article

References (30)

1. McInnes IB, Schett G. The pathogenesis of Rheumatoid Arthritis. N Engl J Med Overseas Ed 2011;365:2205-19.
2. Humira (adalimumab) injection [prescribing information]. North Chicago, IL: AbbVie Inc, 2016.
3. European Medicines Agency Committee for Medicinal Products for Human Use. Summary of opinion (post authorisation). Humira adalimumab http://www. ema.europa. eu/docs/en-GB/document-library/Summary-of-opinion/human/000481/WC500188795. pdf (accessed 6 Jan 2016).
4. US Food and Drug Administration. FDA approves first biosimilar product Zarxio [press release]. http://www. fda. gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648. htm (accessed 10 Apr 2015).
5. Schabert VF, Waston C, Joseph G, et al. Costs of tumor necrosis factor blockers per treated rheumatoid arthritis patient using real-world drug data in a us managed care population [abstract]. Arthritis Rheum 2012;64(suppl 10):S168-S169.
6. Atzinger C, Guo JJ. Php38 utilization, price and spending of anti-tumor necrosis factor biologics in the United States medicaid program. Value in Health 2011;14:A18.
7. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26-37.
8. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
9. European Medicines Agency. Guideline on similar biological medicinal products. http://www. ema. europa. eu/docs/en-GB/document-library/Scientific-guideline/2014/10/WC500176768. pdf (accessed 3 Apr 2015).
10. US Department of Health and Human Services. Biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Guidance for industry. http ://w ww.f da.g ov/d ownl oads/Drugs/GuidanceComplianceRegulato ryIn form ation/Gui dances/UCM444661. pdf (accessed 22 May 2017).
11. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Guidance for industry. http ://w ww.f da.g ov/d ownl oads/drugs/guidancecomplianceregulato ryin form ation/gui dances/ucm291134. pdf (accessed 22 May 2017).
12. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing monoclonal antibodies-non-clinical and clinical issues http://www. ema. europa. eu/docs/en-GB/document-library/Scientific-guideline/2012/06/WC500128686. pdf (accessed 6 Jan 2016).
13. US Department of Health and Human Services. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry http ://w ww.f da.g ov/d ownl oads/Drugs/GuidanceComplianceRegulato ryIn form ation/Gui dances/UCM291128. pdf (accessed 12 May 2015).
14. European Medicines Agency Committee for Medicinal Products for Human Use. Assessment report. Benepali. http://www. ema. europa. eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/004007/WC500200380. pdf (accessed 22 May 2017).
15. European Medicines Agency Committee for Medicinal Products for Human Use. Assessment report. Inflectra. http://www. ema. europa. eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/002778/WC500151490. pdf (accessed 22 May 2017).
16. European Medicines Agency Committee for Medicinal Products for Human Use. CHMP assessment report. Flixabi. http://www. ema. europa. eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/004020/WC500208358. pdf (accessed 22 May 2017).
17. US Food and Drug Administration. FDA approves Inflectra, a biosimilar to Remicade. http://www. fda. gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227. htm (accessed 22 May 2017).
18. INFLECTRA (infliximab-dyyb). Lake Forest, IL: Hospira, 2016.
19. ERELZI (etanercept-szzs) injection, for subcutaneous use [prescribing information]. Stein, Switzerland: Novartis Pharma AG, 2016.
20. AMJEVITA (adalimumab-atto) injection for subcutaneous use [prescribing information]. Thousand Oaks, CA: Amgen Inc, 2016.
21. US Food and Drug Administration. FDA approves Amjevita, a biosimilar to Humira [press release]. http://www. fda. gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243. htm (accessed 22 May 2017) .
22. Liu J, Eris T, Li C, et al. Assessing analytical similarity of proposed amgen biosimilar ABP 501 to adalimumab. BioDrugs 2016;30:321-38.
23. Velayudhan J, Chen YF, Rohrbach A, et al. Demonstration of functional similarity of proposed biosimilar ABP 501 to Adalimumab. BioDrugs 2016;30:339-51.
24. 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;76:526-33.
25. P app K, Bachelez H, Costanzo A, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol2017;76:1093-102.
26. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
27. Colbert A, Umble-Romero A, Prokop S, et al. Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs. MAbs 2014;6:1178-89.
28. US Food and Drug Administration. Guidance for industry: non-inferiority clinical trials. http://www. fda. gov/downloads/Drugs/Guidances/UCM202140. pdf (accessed 10 Apr 2015).
29. US Food and Drug Administration. Guidance for industry: drug-induced livery injury: premarketing clinical evaluation. Silver Spring, MD: US Food and Drug Administration, 2009 (accessed 22 May 2017).
30. Vincent FB, Morand EF, Murphy K, et al. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis 2013;72:165-78.