Asia Biosimilars
Biosimilars: lower-cost copies of biologic drugs, now increasingly made in Asia.
8Tracked assets
8Approved
ApprovedHighest stage
Latest event date
How this track works
A biosimilar is a near-identical version of a biologic drug, such as an antibody, launched after the original's patents expire. Because biologics are made in living cells, a biosimilar must show in analytical and clinical studies that it matches the original, which makes it far harder to develop than a small-molecule generic. South Korea's Celltrion and Samsung Bioepis built global businesses this way, and Chinese and Taiwanese developers now win European approvals, usually selling through Western partners that hold local commercial rights.
Development stage
Approved8
Origin country / region
China3 3
South Korea4 4
Taiwan1 1
Assets
| Rank | Asset | INN | Originator | Country | Targets | Mechanism | Highest stage | Indication | Trial IDs | Overseas rights holder | Deal date | Upfront | Total ceiling | Latest event | Latest event date | Sources | Source date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |