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EPYZTEK (Samsung Bioepis AU Pty Ltd)
Product name
EPYZTEK
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
160 (255 working days)
Active ingredients
Ustekinumab
Registration type
New biosimilar medicine
Indication
Plaque Psoriasis
Adults
EPYZTEK is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Paediatric population, 6 years and older
EPYZTEK is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA)
EPYZTEK, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological DMARD therapy has been inadequate.
Crohn’s Disease
EPYZTEK is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Ulcerative Colitis
EPYZTEK is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.