HADLIMA (Samsung Bioepis AU Pty Ltd)
Product name
HADLIMA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
214 working days (255)
Active ingredients
adalimumab (rch)
Registration type
New biosimilar medicine
Indication
HADLIMA (solution for injection) is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. HADLIMA can be used alone or in combination with methotrexate.