Marketing-authorisation holder
Samsung Bioepis Co., Ltd.
45 medicines in 2 countries, as authorisation holder.
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Marketing-authorisation holder
45 medicines in 2 countries, as authorisation holder.
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Groups are put together by Prognia from the names regulators publish and from company links; they are not an official corporate structure.
Every medicine in the registers under its name, current ones first.
1–25 of 45
| Medicine | Substance | Country | Status | Authorised |
|---|---|---|---|---|
| AYBINTIO100 mg / 4 ml · Solution | Bevacizumab | Canada | Marketed | 2022 |
| AYBINTIO400 mg / 16 ml · Solution | Bevacizumab | Canada | Marketed | 2022 |
| BRENZYS50 mg / ml · Solution | Etanercept | Canada | Marketed | 2016 |
| BRENZYS50 mg / ml · Solution | Etanercept | Canada | Marketed | 2016 |
| BYOOVIZ0.5mg(10mg/ml) · Injectable | Ranibizumab | United States | Marketed | 2021 |
| Byooviz10mg/ml (0.5mg/0.05ml) · Injection | Ranibizumab | United States | Marketed | 2026 |
| DENOSUMAB-DSSB60mg/ml | 70mg/ml · Injectable | Denosumab | United States | Marketed | 2025 |
| EPYSQLI10 mg / ml · Solution | Eculizumab | Canada | Authorised | |
| EPYSQLI300 mg/30 mL (10 mg/mL) · Injection | Eculizumab | United States | Marketed | 2024 |
| Eticovo50mg/ml · Injection | Etanercept | United States | Not marketed | 2024 |
| ETICOVO25mg/0.5ml | 50mg/1ml · Injectable | Etanercept | United States | Marketed | 2019 |
| HADLIMA40 mg / 0.8 ml · Solution | Adalimumab | Canada | Marketed | 2021 |
| Hadlima40mg/0.8ml · Injection | Adalimumab | United States | Marketed | 2019 |
| Hadlima40mg/0.8ml · Injection | Adalimumab | United States | Marketed | 2022 |
| HADLIMA40 mg / 0.4 ml · Solution | Adalimumab | Canada | Marketed | 2023 |
| Hadlima40mg/0.4ml · Injection | Adalimumab | United States | Marketed | 2022 |
| Hadlima80mg/0.8ml · Injection | Adalimumab | United States | Marketed | 2026 |
| HADLIMA40mg/0.8ml · Injectable | Adalimumab | United States | Marketed | 2019 |
| Hadlima40mg/0.4ml · Injection | Adalimumab | United States | Marketed | 2022 |
| HADLIMA PUSHTOUCH40 mg / 0.8 ml · Solution | Adalimumab | Canada | Marketed | 2021 |
| HADLIMA PUSHTOUCH40 mg / 0.4 ml · Solution | Adalimumab | Canada | Marketed | 2023 |
| MELVIZO10 mg / ml · Solution | Ranibizumab | Canada | Marketed | 2023 |
| OBODENCE60 mg / 1 ml · Solution | Denosumab | Canada | Authorised | |
| ONTRUZANT440 mg / vial · Powder For Solution | Trastuzumab | Canada | Marketed | 2022 |
| ONTRUZANT150 mg / vial · Powder For Solution | Trastuzumab | Canada | Marketed | 2022 |
Where it holds or makes medicines, with how many are current.
| Country | Medicines | Current | Past | Companies |
|---|---|---|---|---|
| Canada | 23 | 23 | 0 | CompaniesAll medicines |
| United States | 22 | 22 | 0 | CompaniesAll medicines |
The ATC groups most of its medicines belong to, largest first.
The active substances in most of its medicines.
How the registers spell it, normalised: legal forms, accents and capitals removed.
Compiled by Prognia from the public medicine and company registers below. Logos are not used.
Source: U.S. FDA, Drugs@FDA / openFDA. FDA does not endorse this site.
Licence: Public domain (U.S. Government work)
Health Canada, Drug Product Database, company API, entire response observed 2026-10-10T15:12:05.508784+00:00; native facts projected by Prognia.
Licence: Open Government Licence Canada
Health Canada, Drug Product Database, drugproduct API, entire response observed 2026-10-10T15:12:07.336870+00:00; native facts projected by Prognia.
Licence: Open Government Licence Canada
FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.
Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions
Report an error or request removalCorrections from the company itself are welcome.