Biosymilars in the treatment of rheumatic diseases;Lekibiopodobne stosowane w reumatologii

Reumatologia

Volumn 51, Issue 6, 2013, Pages 399-408

  Wiland, Piotr ^a  

^a WROCLAW MEDICAL UNIVERSITY   (Poland)

Author keywords

Ankylosing spondylitis; Biosimilars; Rheumatoid arthritis; TNF inhibitors

Indexed keywords

BIOSIMILAR AGENT; CT P 13; INFLIXIMAB; METHOTREXATE; UNCLASSIFIED DRUG;

ANKYLOSING SPONDYLITIS; DRUG EFFICACY; DRUG SAFETY; HUMAN; MONOTHERAPY; PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; RHEUMATIC DISEASE; RHEUMATOID ARTHRITIS;

EID: 84892691131     PISSN: 00346233     EISSN: None     Source Type: Journal    
DOI: 10.5114/reum.2013.39657     Document Type: Review

References (16)

1. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drug 2011; 71: 1527-1536.
2. Kresse GB. Biosimilars - science, status and strategic perspectives. Eur J Pharm Biopharm 2009; 72: 479-486.
3. World Health Organization. Expert committee on biological standarization Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutics products [SBPs], http:/www.who.int/biological/areas/biological- therapeutics/BIOTHERAPEUTICS-FOR-WEB-22APRIL2010.pdg (accessed 10 Sep 2012).
4. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ general-content-000408.jsp&mid=WC0b01ac058002958c.
5. Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotech 2011; 29: 310-312.
6. European Medicines Agency. 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
7. European Medicines Agency. Summary of opinion (initial authorisation) Remsima (infliximab). http://www.ema.europa.eu/docs/en-GB/document-library/ Summary-of-opinion---Initial-authorisation/human/002576/WC500144832.pdf]
8. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999; 354: 1932-1939.
9. Lipsky PE, van der Heijde DM, St Clair EW, et al.; Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000; 343: 1594-1602.
10. Yoo DH, Hrycaj P, Miranda P, et al. A randomized, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; May 21 [Epub ahead print].
11. Dranitsaris G, Dorward K, Hatzimichael E, Amir E. Clinical trial design in biosimilar drug development. Invest New Drugs 2013; 31: 479-487.
12. Fletcher MP. Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches. Biologicals 2011; 39: 270-277.
13. Westhovens R, Yocum D, Han J, et al. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial. Arthritis Rheum 2006; 54: 1075-1086.
14. Yoo DH, Racewicz A, Brzezicki J, et al. A phase 3 randomized controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study. Ann Rheum Dis 2013; 72: OP0068 (Suppl 3).
15. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre paralel - group, prospective study comparing pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study, Ann Rheum Dis 2013; May 16 [Epub ahead of print].
16. Park W, Jaworski J, Brzezicki J, et al. A randomized, double-blind, paralel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study. Ann Rheum Dis 2013; 72; FRI0421 (Suppl 3).