Biosimilars: Clinical Interpretation and Implications for Drug Development

Current Rheumatology Reports

Volumn 17, Issue 2, 2015, Pages

  Mysler, Eduardo ^a  

^a Organización Médica de Investigación   (Argentina)

Author keywords

Biologics; Biosimilars: clinical aspects; Clinical trials; Efficacy; Safety

Indexed keywords

BIOSIMILAR AGENT;

BIOEQUIVALENCE; CLINICAL EFFECTIVENESS; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG COST; DRUG DESIGN; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; HUMAN; INFLAMMATORY BOWEL DISEASE; MEDICAL LITERATURE; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; DRUG SUBSTITUTION; PROCEDURES; RHEUMATIC DISEASES;

BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; DRUG SUBSTITUTION; HUMANS; RHEUMATIC DISEASES;

EID: 84921522818     PISSN: 15233774     EISSN: 15346307     Source Type: Journal    
DOI: 10.1007/s11926-014-0483-y     Document Type: Review

References (25)

1. Pollack A. The New York Times. Published: January 28, 2013. (http://www.nytimes.com/2013/01/29/business/battle-in-states-on-generic-copies-of-biotech-drugs).
2. Mysler E, Scheinberg. Biosimilars in rheumatology. A view from Latin America. Clin Rheumatol. 2012;31(9):1279–80.
3. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology: American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic diseasemodifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59:762–84.
4. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;7:315–8.
5. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), et al. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (draft). 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf (accessed May 2013).
6. World Health Organization (WHO). Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf (accessed May 2013).
7. Guideline on the clinical investigation of the pharmacokinetics of 228 therapeutic proteins (CHMP/EWP/89249/2004).
8. Expert committee on biological standardization, Geneva, 19 to 23 October 2009 Guidelines on evaluation of similar biotherapeuthic products (SBPs, WHO).
9. Guideline on the choice of the non-inferiority margin. (http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf).
10. Joung J, Robertson JS, Griffiths E, Knezevic I. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Genebra, 19–20 April 2007. Biologicals. 2008;36(4):269–76.
11. Laster LL, Johnson MF, Kotler ML. Non-inferiority trial: the at least as good as’ criterion with dichotomous data. Stat Med. 2006;25:1115–30.
12. Dorner T, Strand V, Castaneda-Hernandez G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis. 2013;72:322–8.
13. Sandborn WJ, Hanauer SB, Katz S, Safdi M, Wolf DG, Baerg RD, et al. Etanercept for active Crohn’s disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2001;121(5):1088–94.
14. Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132(1):52–65.
15. Keystone E, Genovese MC, Klareskog L, Hsia EC, Hall S, Miranda PC, et al. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study. Ann Rheum Dis. 2010;69(6):1129–35.
16. Smolen JS, Kay J, Doyle MK, Landewé R, Matteson EL, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374(9685):210–21.
17. Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272–83.
18. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMA 03 June May 2013 EMEA/CHMP/BMWP/42832/2005 Rev. Committee for Medicinal Products for Human Use (CHMP).
19. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs. 2011;71:1527–36.
20. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins EMEA/CHMP/BMWP/14327/2006.
21. Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use. EMA/CHMP/BMWP/86289/2010.
22. Krieckaert CL, Jamnitski A, Nurmohamed MT, Kostense PJ, Boers M, Wolbink G. Comparison of long-term clinical outcome with etanercept treatment and adalimumab treatment of rheumatoid arthritis with respect to immunogenicity. Arthritis Rheum. 2012;64(12):3850–5.
23. WHO Drug Information Vol 23, No. 2, 2009
24. Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther. 2002;24:1720–40.
25. Lamarque V, Merle L. Generics and substitution modalities: proposed methods for the evaluation of equivalence, traceability and pharmacovigilance reporting. Therapie. 2008;63:311–9.