Sponsor Dossier
Samsung Bioepis AU
Sponsor Dossier for Samsung Bioepis AU. ARTG portfolio, PBS-listed brands, PBAC activity, AusPAR record — compiled by arcimedes.
- Brand: BRENZYS
- Brand: BYOOVIZ
- Brand: EPYZTEK
- Brand: HADLIMA
- Brand: ONBEVZI
- Brand: ONTRUZANT
- Brand: OPUVIZ
- Brand: OSPOMYV
- Device (sponsor): Surgical procedure kit, ophthalmic, medicated, single-use
About
Samsung Bioepis AU is an Australian Private Company with ABN 25611890094, registered in New South Wales with active status.
Portfolio
Samsung Bioepis AU has 10 brands on the ARTG, with 9 indexable brands and 3 brands with Product Information on file. The portfolio includes 2 brands with at least one PBS-listed item, 4 brands with PBAC outcome records, and 7 brands with AusPARs on record. Notable brands include BRENZYS, BYOOVIZ, EPYZTEK, HADLIMA, ONBEVZI, ONTRUZANT, OPUVIZ, OSPOMYV, RENFLEXIS, and XBORSO.
Therapeutic focus —
Oncology: 4 brands — Immunology: 3 brands — Ophthalmology: 2 brands — Infectious Disease: 1 brand
PBS footprint
Two brands in the portfolio are PBS-listed, with the latest PBS schedule date touched on 1 May 2026.
Regulatory activity
Samsung Bioepis AU has 4 brands with PBAC outcomes on record, with the most recent outcome dated 1 December 2020. Seven brands in the portfolio have AusPARs on record, with the latest AusPAR dated 10 September 2025.