A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers

Journal of Clinical Pharmacy and Therapeutics

Volumn 42, Issue 6, 2017, Pages 672-678

  Shin, D ^a   Lee, Y ^a   Kim, H ^a   Kornicke T ^b   Fuhr, R ^b  

^a Samsung Bioepis Co Ltd   (South Korea)

^b PAREXEL INTERNATIONAL   (United States)

Author keywords

bioequivalence; biosimilar; clinical pharmacokinetics

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; DRUG ANTIBODY; NEUTRALIZING ANTIBODY; SB 5;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HERPES LABIALIS; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PARALLEL DESIGN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; RHINOPHARYNGITIS; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; SKIN REDNESS; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; CLINICAL TRIAL; THERAPEUTIC EQUIVALENCE;

ADALIMUMAB; ADULT; AREA UNDER CURVE; BIOSIMILAR PHARMACEUTICALS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; MALE; SINGLE-BLIND METHOD; THERAPEUTIC EQUIVALENCY;

EID: 85021827152     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/jcpt.12583     Document Type: Article

References (20)

1. Birnbaum H, Pike C, Kaufman R, Maynchenko M, Kidolezi Y, Cifaldi M. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. 2010;26:77-90.
2. 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.
3. 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.
4. Smolen JS, Landewé 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.
5. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet. 1999;354:1932-1939.
6. Ma X, Xu S. TNF inhibitor therapy for rheumatoid arthritis (review). Biomed Rep. 2013;1:177-184.
7. Mease PJ. Adalimumab in the treatment of arthritis. Ther Clin Risk Manag. 2007;3:133-148.
8. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. European Medicines Agency; 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed August 21, 2016.
9. Dorner T, Strand V, Castañeda-Hernández G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis. 2013;72:322-328.
10. Sitte HH, Freissmuth M. Biosimilars versus generics: scientific basics and clinical implications. Memo. 2013;6:202-206.
11. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medicines Agency; 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Accessed August 21, 2016.
12. ®) in healthy subjects. Ann Rheum Dis. 2015;74(suppl 2):459-460.
13. ® Prescribing Information. North Chicago, IL: Abbvie Inc.
14. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. European Medicines Agency; 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf. Accessed August 21, 2016.
15. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing monoclonal antibodies – nonclinical and clinical issues. European Medicines Agency; 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf. Accessed 21 August 2016.
16. ®) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (24-week results) [abstract]. Arthritis Rheumatol. 2015;67(suppl 10). http://acrabstracts.org/abstract/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/. Accessed August 21, 2016.
17. US Food and Drug Administration (FDA). Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products – general considerations; 2003. https://www.fda.gov/ohrms/dockets/ac/03/briefing/3995B1_07_GFI-BioAvail-BioEquiv.pdf. Accessed April 13, 2017.
18. Alten R, Cronstein B. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015;44:S2-S8.
19. Bartelds GM, Krieckaert CLM, 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;305:1460-1468.
20. Chirmule N, Jawa V, Meibohm B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. AAPS. 2012;14:296-302.