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REMSIMA, biosimilars of infliximab, TNF inhibitor

RHEUMATOLOGY – GASTROENTEROLOGY – DERMATOLOGY - New medicinal product
Opinions on drugs - Posted on Sep 09 2016

Reason for request

Inclusion

No clinical benefit demonstrated relative to REMICADE (reference biotherapy).

  • INFLECTRA, REMSIMA and FLIXABI are biosimilars. of REMICADE. They have the same indications as REMICADE in rheumatology (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), gastroenterology (ulcerative colitis and Crohn’s disease) and dermatology (psoriasis). The have the same strenght, the same pharmaceutical form, the same administration route and the same composition of excipients as REMICADE.
  • The bioequivalence of these biosimilars to REMICADE has been demonstrated in a pharmacokinetic study performed in patients with ankylosing spondylitis (INFLECTRA and REMSIMA) and in healthy volunteers for FLIXABI. Their clinical equivalence was assessed in patients with rheumatoid arthritis.




Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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