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IXIFI (Pfizer Australia Pty Ltd)
Product name
IXIFI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
153 (255 working days)
Active ingredients
Infliximab
Registration type
New biosimilar medicine
Indication
Rheumatoid Arthritis in adults
IXIFI, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in:
- patients with active disease despite treatment with methotrexate
- patients with active disease who have not previously received methotrexate.
IXIFI should be given in combination with methotrexate. Efficacy and safety in Rheumatoid Arthritis have been demonstrated only in combination with methotrexate.
Ankylosing Spondylitis
IXIFI is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.
Psoriatic arthritis
IXIFI is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (DMARD) therapy.
IXIFI may be administered in combination with methotrexate.
Psoriasis
IXIFI is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. Safety and efficacy beyond 12 months have not been established.
Crohn’s Disease in Adults and in Children and adolescents (6 to 17 years)
IXIFI is indicated for the treatment of moderate to severe Crohn’s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.
Refractory Fistulising Crohn’s Disease
IXIFI is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.
Ulcerative colitis in Adults and in Children and adolescents (6 to 17 years)
IXIFI is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.