I. Introduction to product submission Submission details Type of submission: Biosimilar medicine Decision: Approved Date of decision: 18 October 2017 Date of entry onto ARTG 9 November 2017 Active ingredient: Adalimumab Product name: Amgevita Sponsor’s name and address: Amgen Australia Pty Ltd 115 Cotham Road Kew, VIC, 3101 Dose forms: Pre-filled syringe and Pre-filled syringe with pen injector Strengths: 20 mg/ 0.4 mL and 40 mg/ 0.8 mL Container: Pre-filled syringe Pack sizes: Amgevita 20 mg solution for injection in single-use pre-filled syringe: Carton containing 1 pre-filled syringe Carton containing 2 pre-filled syringes Amgevita 40 mg solution for injection in single-use pre-filled syringe or pre-filled SureClick pen (for patient use): Carton containing 1 pre-filled syringe or pre-filled pen Carton containing 2 pre-filled syringes or pre-filled pens Carton containing 4 pre-filled syringes or pre-filled pens Carton containing 6 pre-filled syringes or pre-filled pens. Approved therapeutic use: Rheumatoid Arthritis Amgevita is indicated for reducing 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. Amgevita can be used alone or in combination with methotrexate. Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis
I. Introduction to product submission Submission details Type of submission: Biosimilar medicine Decision: Approved Date of decision: 18 October 2017 Date of entry onto ARTG 9 November 2017 Active ingredient: Adalimumab Product name: Amgevita Sponsor’s name and address: Amgen Australia Pty Ltd 115 Cotham Road Kew, VIC, 3101 Dose forms: Pre-filled syringe and Pre-filled syringe with pen injector Strengths: 20 mg/ 0.4 mL and 40 mg/ 0.8 mL Container: Pre-filled syringe Pack sizes: Amgevita 20 mg solution for injection in single-use pre-filled syringe: Carton containing 1 pre-filled syringe Carton containing 2 pre-filled syringes Amgevita 40 mg solution for injection in single-use pre-filled syringe or pre-filled SureClick pen (for patient use): Carton containing 1 pre-filled syringe or pre-filled pen Carton containing 2 pre-filled syringes or pre-filled pens Carton containing 4 pre-filled syringes or pre-filled pens Carton containing 6 pre-filled syringes or pre-filled pens. Approved therapeutic use: Rheumatoid Arthritis Amgevita is indicated for reducing 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. Amgevita can be used alone or in combination with methotrexate. Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis
auspar-adalimumab-180625.docx