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, of which 10 are indexable and 3 carry a Product Information document. 3 brands are PBS-listed, 5 have a PBAC outcome on record, and 8 have an AusPAR on record. Notable brands include BRENZYS, BYOOVIZ, EPYZTEK, HADLIMA, ONBEVZI, ONTRUZANT, OPUVIZ, OSPOMYV, RENFLEXIS, XBORSO.
Therapeutic focus
— Immunology: 3 brands — Oncology: 3 brands — Ophthalmology: 2 brands — Musculoskeletal: 2 brands
PBS footprint
3 brands are PBS-listed, with the latest PBS schedule date 2026-10-01.
Regulatory activity
The latest PBAC outcome is 2025-03-01, across 5 brands with a PBAC outcome on record. The latest AusPAR is 2026-03-26, across 8 brands with an AusPAR on record.