{
  "as_of": "2026-11-03",
  "track": "biosimilars-cdmo",
  "source_url": "https://drugnews.com.tw/en/asia-biosimilars-cdmo-leaders.html",
  "headers": [
    "rank",
    "asset",
    "inn",
    "originator",
    "country",
    "target",
    "mechanism",
    "highest_stage",
    "indications",
    "trial_ids",
    "overseas_rights_holder",
    "deal_date",
    "upfront",
    "total_value",
    "latest_event",
    "latest_event_date",
    "source_urls",
    "source_date"
  ],
  "rows": [
    [
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/usymro | https://bet.hu/newkibdata/129309232/USYMRO_EC_approval_Aug_2025_ENG.pdf | https://clinicaltrials.gov/study/NCT04728360",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz | https://www.samsungbioepis.com/en/newsroom/newsroomView.do?currentPage=1&idx=561 | https://clinicaltrials.gov/study/NCT04450329",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma | https://www.celltrion.com/en-us/products/approved/biologics | https://www.celltrion.com/en-us/company/media-center/stories/4772 | https://clinicaltrials.gov/study/NCT04673786",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/omlyclo | https://www.celltrion.com/en-us/products/approved/biologics | https://www.celltrion.com/en-us/company/media-center/stories/4772 | https://clinicaltrials.gov/study/NCT04426890",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva | https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=389 | https://clinicaltrials.gov/study/NCT04967508",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/rimmyrah | https://www.qilu-pharma.com/news_details/299.html | https://clinicaltrials.gov/study/NCT03312283",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda | https://wwwc.twse.com.tw/market_insights/en/detail/8a8216d697fc438f019812525f810069 | https://clinicaltrials.gov/study/NCT03433313",
      "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",
      "https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac | https://www.henlius.com/en/newsd/0/22670.html | https://clinicaltrials.gov/study/NCT03084237",
      "2026-09-09"
    ]
  ],
  "row_sources": [
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/usymro",
        "source_date": "2026-10-06"
      },
      {
        "url": "https://bet.hu/newkibdata/129309232/USYMRO_EC_approval_Aug_2025_ENG.pdf",
        "source_date": "2026-10-06"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT04728360",
        "source_date": "2026-10-06"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz",
        "source_date": "2026-10-19"
      },
      {
        "url": "https://www.samsungbioepis.com/en/newsroom/newsroomView.do?currentPage=1&idx=561",
        "source_date": "2026-10-19"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT04450329",
        "source_date": "2026-10-19"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma",
        "source_date": "2026-10-06"
      },
      {
        "url": "https://www.celltrion.com/en-us/products/approved/biologics",
        "source_date": "2026-10-06"
      },
      {
        "url": "https://www.celltrion.com/en-us/company/media-center/stories/4772",
        "source_date": "2026-10-06"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT04673786",
        "source_date": "2026-10-06"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/omlyclo",
        "source_date": "2026-05-11"
      },
      {
        "url": "https://www.celltrion.com/en-us/products/approved/biologics",
        "source_date": "2026-05-11"
      },
      {
        "url": "https://www.celltrion.com/en-us/company/media-center/stories/4772",
        "source_date": "2026-05-11"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT04426890",
        "source_date": "2026-05-11"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva",
        "source_date": "2026-10-27"
      },
      {
        "url": "https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=389",
        "source_date": "2026-10-27"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT04967508",
        "source_date": "2026-10-27"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/rimmyrah",
        "source_date": "2026-08-21"
      },
      {
        "url": "https://www.qilu-pharma.com/news_details/299.html",
        "source_date": "2026-08-21"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT03312283",
        "source_date": "2026-08-21"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda",
        "source_date": "2026-08-18"
      },
      {
        "url": "https://wwwc.twse.com.tw/market_insights/en/detail/8a8216d697fc438f019812525f810069",
        "source_date": "2026-08-18"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT03433313",
        "source_date": "2026-08-18"
      }
    ],
    [
      {
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac",
        "source_date": "2026-09-09"
      },
      {
        "url": "https://www.henlius.com/en/newsd/0/22670.html",
        "source_date": "2026-09-09"
      },
      {
        "url": "https://clinicaltrials.gov/study/NCT03084237",
        "source_date": "2026-09-09"
      }
    ]
  ],
  "records": [
    {
      "rank": "1",
      "asset": "Usymro",
      "inn": "ustekinumab",
      "originator": "Bio-Thera Solutions",
      "country": "China",
      "target": "IL-12 / IL-23",
      "mechanism": "IL-12/IL-23-blocking monoclonal antibody; Stelara biosimilar",
      "highest_stage": "Approved — EU (2025-08)",
      "indications": "Plaque psoriasis; psoriatic arthritis; Crohn disease; ulcerative colitis",
      "trial_ids": "NCT04728360",
      "overseas_rights_holder": "Gedeon Richter (EU, UK, Switzerland and selected other countries)",
      "deal_date": "2024-10",
      "upfront": "Not disclosed",
      "total_value": "Not disclosed",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-10-06",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/usymro | https://bet.hu/newkibdata/129309232/USYMRO_EC_approval_Aug_2025_ENG.pdf | https://clinicaltrials.gov/study/NCT04728360",
      "source_date": "2026-10-06"
    },
    {
      "rank": "2",
      "asset": "Opuviz",
      "inn": "aflibercept",
      "originator": "Samsung Bioepis",
      "country": "South Korea",
      "target": "VEGF-A / PlGF",
      "mechanism": "VEGF-binding fusion protein; Eylea biosimilar",
      "highest_stage": "Approved — EU (2024-11)",
      "indications": "Wet age-related macular degeneration; retinal-vein-occlusion or diabetic macular oedema; myopic choroidal neovascularisation",
      "trial_ids": "NCT04450329",
      "overseas_rights_holder": "None reported",
      "deal_date": "—",
      "upfront": "—",
      "total_value": "—",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-10-19",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz | https://www.samsungbioepis.com/en/newsroom/newsroomView.do?currentPage=1&idx=561 | https://clinicaltrials.gov/study/NCT04450329",
      "source_date": "2026-10-19"
    },
    {
      "rank": "3",
      "asset": "Steqeyma",
      "inn": "ustekinumab",
      "originator": "Celltrion",
      "country": "South Korea",
      "target": "IL-12 / IL-23",
      "mechanism": "IL-12/IL-23-blocking monoclonal antibody; Stelara biosimilar",
      "highest_stage": "Approved — EU (2024-08)",
      "indications": "Plaque psoriasis; psoriatic arthritis; Crohn disease; ulcerative colitis",
      "trial_ids": "NCT04673786",
      "overseas_rights_holder": "None reported",
      "deal_date": "—",
      "upfront": "—",
      "total_value": "—",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-10-06",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma | https://www.celltrion.com/en-us/products/approved/biologics | https://www.celltrion.com/en-us/company/media-center/stories/4772 | https://clinicaltrials.gov/study/NCT04673786",
      "source_date": "2026-10-06"
    },
    {
      "rank": "4",
      "asset": "Omlyclo",
      "inn": "omalizumab",
      "originator": "Celltrion",
      "country": "South Korea",
      "target": "IgE",
      "mechanism": "IgE-binding monoclonal antibody; Xolair biosimilar",
      "highest_stage": "Approved — EU (2024-05)",
      "indications": "Allergic asthma; nasal polyps; chronic spontaneous urticaria",
      "trial_ids": "NCT04426890",
      "overseas_rights_holder": "None reported",
      "deal_date": "—",
      "upfront": "—",
      "total_value": "—",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-05-11",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/omlyclo | https://www.celltrion.com/en-us/products/approved/biologics | https://www.celltrion.com/en-us/company/media-center/stories/4772 | https://clinicaltrials.gov/study/NCT04426890",
      "source_date": "2026-05-11"
    },
    {
      "rank": "5",
      "asset": "Pyzchiva",
      "inn": "ustekinumab",
      "originator": "Samsung Bioepis",
      "country": "South Korea",
      "target": "IL-12 / IL-23",
      "mechanism": "IL-12/IL-23-blocking monoclonal antibody; Stelara biosimilar",
      "highest_stage": "Approved — EU (2024-04)",
      "indications": "Plaque psoriasis; psoriatic arthritis; Crohn disease",
      "trial_ids": "NCT04967508",
      "overseas_rights_holder": "Sandoz (US, Canada, EEA, Switzerland and UK)",
      "deal_date": "2023-09",
      "upfront": "Not disclosed",
      "total_value": "Not disclosed",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-10-27",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva | https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=389 | https://clinicaltrials.gov/study/NCT04967508",
      "source_date": "2026-10-27"
    },
    {
      "rank": "6",
      "asset": "Rimmyrah",
      "inn": "ranibizumab",
      "originator": "Qilu Pharmaceutical",
      "country": "China",
      "target": "VEGF-A",
      "mechanism": "VEGF-A-binding antibody fragment; Lucentis biosimilar",
      "highest_stage": "Approved — EU (2024-01)",
      "indications": "Wet age-related macular degeneration; diabetic or retinal-vein-occlusion macular oedema; proliferative diabetic retinopathy; choroidal neovascularisation",
      "trial_ids": "NCT03312283",
      "overseas_rights_holder": "None reported",
      "deal_date": "—",
      "upfront": "—",
      "total_value": "—",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-08-21",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/rimmyrah | https://www.qilu-pharma.com/news_details/299.html | https://clinicaltrials.gov/study/NCT03312283",
      "source_date": "2026-08-21"
    },
    {
      "rank": "7",
      "asset": "Herwenda",
      "inn": "trastuzumab",
      "originator": "EirGenix",
      "country": "Taiwan",
      "target": "HER2",
      "mechanism": "HER2-directed monoclonal antibody; Herceptin biosimilar",
      "highest_stage": "Approved — EU (2023-11)",
      "indications": "HER2-positive breast cancer; metastatic gastric cancer",
      "trial_ids": "NCT03433313",
      "overseas_rights_holder": "Sandoz (European commercial partner and EU MAH)",
      "deal_date": "Not disclosed",
      "upfront": "Not disclosed",
      "total_value": "Not disclosed",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-08-18",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda | https://wwwc.twse.com.tw/market_insights/en/detail/8a8216d697fc438f019812525f810069 | https://clinicaltrials.gov/study/NCT03433313",
      "source_date": "2026-08-18"
    },
    {
      "rank": "8",
      "asset": "Zercepac",
      "inn": "trastuzumab",
      "originator": "Shanghai Henlius Biotech",
      "country": "China",
      "target": "HER2",
      "mechanism": "HER2-directed monoclonal antibody; Herceptin biosimilar",
      "highest_stage": "Approved — EU (2020-07)",
      "indications": "HER2-positive breast cancer; metastatic gastric cancer",
      "trial_ids": "NCT03084237",
      "overseas_rights_holder": "Accord Healthcare (EU commercial partner); Accord Healthcare S.L.U. (EU MAH)",
      "deal_date": "Not disclosed",
      "upfront": "Not disclosed",
      "total_value": "Not disclosed",
      "latest_event": "EMA public record updated; administrative update, not a new approval",
      "latest_event_date": "2026-09-09",
      "source_urls": "https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac | https://www.henlius.com/en/newsd/0/22670.html | https://clinicaltrials.gov/study/NCT03084237",
      "source_date": "2026-09-09"
    }
  ]
}