eISSN: 2084-9834
ISSN: 0034-6233
Reumatologia/Rheumatology
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6/2013
vol. 51
 
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abstract:
Editorial

Biosymilars in the treatment of rheumatic diseases

Piotr Wiland

Reumatologia 2013; 51, 6: 399–408
Online publish date: 2013/12/24
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The availability of biosimilar versions of biopharmaceuticals with comparative efficacy and safety but at a lower cost may increase the number of patients treated with biological agents. CT-P13 is a biosimilar infliximab that was compared to innovator infliximab in two clinical trials to assess its potential non-inferiority to the reference product according to the EMA guidelines. The PLANETRA trial was a phase III study that evaluated the efficacy and safety of CT-P13 compared to infliximab in combination with methotrexate in 602 patients with active rheumatoid arthritis. The PLANETAS trial was a phase I study that compared the pharmacokinetics, efficacy and safety of both agents as monotherapy in 250 patients with ankylosing spondylitis. Both studies are the first clinical trials to demonstrate unequivocal efficacy and safety of a biosimilar for the treatment.
keywords:

biosimilars, TNF inhibitors, rheumatoid arthritis, ankylosing spondylitis



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