亞洲 生物相似藥
生物相似藥：生物藥的平價版，越來越多由亞洲公司做出來。
8追蹤資產
8已核准
已核准最高階段
最新事件日期
這個賽道在做什麼
生物相似藥是原廠生物藥（例如抗體）專利到期後推出、與原廠幾乎一樣的版本。生物藥是用活細胞生產的，生物相似藥必須用分析與臨床研究證明和原廠相當，開發難度遠高於小分子學名藥。韓國的 Celltrion 與 Samsung Bioepis 靠這條路做成全球生意；中國與台灣的開發商現在也陸續拿到歐盟核准，通常透過握有當地銷售權的歐美夥伴銷售。
階段分布
已核准8
國家分布
中國3 3
韓國4 4
台灣1 1
資產表
| 排名 | 資產 | 國際非專利名稱 | 原研公司 | 國家 | 標的 | 機轉 | 最高階段 | 適應症 | 試驗登錄號 | 海外權利人 | 交易日期 | 首付款 | 總額上限 | 最新事件 | 最新事件日期 | 來源 | 來源日期 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Usymro | ustekinumab | Bio-Thera Solutions | China | IL-12 / IL-23 | IL-12/IL-23-blocking monoclonal antibody; Stelara biosimilar | Approved — EU (2025-08) | Plaque psoriasis; psoriatic arthritis; Crohn disease; ulcerative colitis | NCT04728360 | Gedeon Richter (EU, UK, Switzerland and selected other countries) | 2024-10 | Not disclosed | Not disclosed | EMA public record updated; administrative update, not a new approval | 2026-10-06 | 1 2 3 | 2026-10-06 |
| 2 | Opuviz | aflibercept | Samsung Bioepis | South Korea | VEGF-A / PlGF | VEGF-binding fusion protein; Eylea biosimilar | Approved — EU (2024-11) | Wet age-related macular degeneration; retinal-vein-occlusion or diabetic macular oedema; myopic choroidal neovascularisation | NCT04450329 | None reported | — | — | — | EMA public record updated; administrative update, not a new approval | 2026-10-19 | 1 2 3 | 2026-10-19 |
| 3 | Steqeyma | ustekinumab | Celltrion | South Korea | IL-12 / IL-23 | IL-12/IL-23-blocking monoclonal antibody; Stelara biosimilar | Approved — EU (2024-08) | Plaque psoriasis; psoriatic arthritis; Crohn disease; ulcerative colitis | NCT04673786 | None reported | — | — | — | EMA public record updated; administrative update, not a new approval | 2026-10-06 | 1 2 3 4 | 2026-10-06 |
| 4 | Omlyclo | omalizumab | Celltrion | South Korea | IgE | IgE-binding monoclonal antibody; Xolair biosimilar | Approved — EU (2024-05) | Allergic asthma; nasal polyps; chronic spontaneous urticaria | NCT04426890 | None reported | — | — | — | EMA public record updated; administrative update, not a new approval | 2026-05-11 | 1 2 3 4 | 2026-05-11 |
| 5 | Pyzchiva | ustekinumab | Samsung Bioepis | South Korea | IL-12 / IL-23 | IL-12/IL-23-blocking monoclonal antibody; Stelara biosimilar | Approved — EU (2024-04) | Plaque psoriasis; psoriatic arthritis; Crohn disease | NCT04967508 | Sandoz (US, Canada, EEA, Switzerland and UK) | 2023-09 | Not disclosed | Not disclosed | EMA public record updated; administrative update, not a new approval | 2026-10-27 | 1 2 3 | 2026-10-27 |
| 6 | Rimmyrah | ranibizumab | Qilu Pharmaceutical | China | VEGF-A | VEGF-A-binding antibody fragment; Lucentis biosimilar | Approved — EU (2024-01) | Wet age-related macular degeneration; diabetic or retinal-vein-occlusion macular oedema; proliferative diabetic retinopathy; choroidal neovascularisation | NCT03312283 | None reported | — | — | — | EMA public record updated; administrative update, not a new approval | 2026-08-21 | 1 2 3 | 2026-08-21 |
| 7 | Herwenda | trastuzumab | EirGenix | Taiwan | HER2 | HER2-directed monoclonal antibody; Herceptin biosimilar | Approved — EU (2023-11) | HER2-positive breast cancer; metastatic gastric cancer | NCT03433313 | Sandoz (European commercial partner and EU MAH) | Not disclosed | Not disclosed | Not disclosed | EMA public record updated; administrative update, not a new approval | 2026-08-18 | 1 2 3 | 2026-08-18 |
| 8 | Zercepac | trastuzumab | Shanghai Henlius Biotech | China | HER2 | HER2-directed monoclonal antibody; Herceptin biosimilar | Approved — EU (2020-07) | HER2-positive breast cancer; metastatic gastric cancer | NCT03084237 | Accord Healthcare (EU commercial partner); Accord Healthcare S.L.U. (EU MAH) | Not disclosed | Not disclosed | Not disclosed | EMA public record updated; administrative update, not a new approval | 2026-09-09 | 1 2 3 | 2026-09-09 |