Celltrion
Biosimilar developer, South Korea. 10 development products across 10 molecules: adalimumab, aflibercept, bevacizumab, denosumab, infliximab, omalizumab, rituximab, tocilizumab, trastuzumab, ustekinumab.
About Celltrion
Celltrion made the first antibody biosimilar approved in the West, its infliximab, in Europe in 2013, and has since built the largest antibody biosimilar portfolio of any company: ten molecules, all approved in the United States, Europe and Canada, eight in Japan. Its Japanese products are sold by Nippon Kayaku and its Gulf registrations come through Hikma, its manufacturing partner in Jordan. In 2025 and 2026 it added denosumab, tocilizumab, omalizumab and aflibercept, and its tocilizumab is the only one interchangeable in both forms in the United States. Its infliximab is also the only one with an under-the-skin version.
Portfolio by market
| Molecule | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE | Markets |
|---|---|---|---|---|---|---|---|---|---|
| Adalimumab | Yuflyma CT-P17 | May 2023 | Feb 2021 | MHRA | Sep 2023 | Dec 2021 | · | · | 5/7 |
| Aflibercept | Eydenzelt CT-P42 | Oct 2025 | Feb 2025 | MHRA | Mar 2026 | Nov 2025 | · | · | 5/7 |
| Bevacizumab | Vegzelma CT-P16 | Sep 2022 | Aug 2022 | MHRA | Sep 2022 | Jan 2023 | · | · | 5/7 |
| Denosumab | Stoboclo / Osenvelt CT-P41 | Feb 2025 | Feb 2025 | MHRA | · | Sep 2025 | · | · | 4/7 |
| Infliximab | Remsima / Inflectra CT-P13 | Apr 2016 | Sep 2013 | MHRA | Jul 2014 | Jan 2014 | Sep 2021 | Jun 2017 | 7/7 |
| Omalizumab | Omlyclo CT-P39 | Mar 2025 | May 2024 | MHRA | Mar 2026 | Dec 2024 | · | · | 5/7 |
| Rituximab | Truxima / Blitzima CT-P10 | Nov 2018 | Feb 2017 | MHRA | · | Apr 2019 | · | Apr 2020 | 5/7 |
| Tocilizumab | Avtozma CT-P47 | Jan 2025 | Feb 2025 | MHRA | Sep 2025 | Oct 2025 | · | · | 5/7 |
| Trastuzumab | Herzuma CT-P6 | Dec 2018 | Feb 2018 | MHRA | Mar 2018 | Sep 2019 | · | Apr 2020 | 6/7 |
| Ustekinumab | Steqeyma CT-P43 | Dec 2024 | Aug 2024 | MHRA | Mar 2025 | Jul 2024 | · | · | 5/7 |
Month shown is the first approval or registration of that product in that market.
In development
ClinicalTrials.gov lists two comparative trials sponsored by Celltrion for two molecules: bevacizumab, rituximab. All of these candidates already have at least one approval in the seven markets.
| Molecule | Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|---|
| Bevacizumab | CT-P16 | Celltrion | Avastin | Phase 1 | Comparative PK | Completed | Aug 2017 | Dec 2017 | Vegzelma | NCT03247673 |
| Rituximab | CT-P10 | Celltrion | MabThera | Phase 1 | Comparative PK | Completed | Feb 2012 | Aug 2013 | Truxima / Blitzima | NCT01534884 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.
Companies on the same molecules
Developers whose portfolios overlap most with Celltrion, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.
Chronology
- EMASep 2013Remsima, infliximab
- HCJan 2014Remdantry, infliximab
- PMDAJul 2014Infliximab BS NK, infliximab
- FDAApr 2016Inflectra, infliximab
- EMAFeb 2017Truxima, rituximab
- EDEJun 2017Remsima, infliximab
- EMAJul 2017Blitzima, rituximab
- EMAFeb 2018Herzuma, trastuzumab
- PMDAMar 2018Trastuzumab BS NK, trastuzumab
- FDANov 2018Truxima, rituximab
- FDADec 2018Herzuma, trastuzumab
- HCApr 2019Truxima, rituximab
- HCSep 2019Herzuma, trastuzumab
- EDEApr 2020Herzuma, trastuzumab
- EDEApr 2020Truxima, rituximab
- HCJan 2021Remsima SC, infliximab
- EMAFeb 2021Yuflyma, adalimumab
- CDSCOSep 2021Pfizer (INN only), infliximab
- HCDec 2021Yuflyma, adalimumab
- EMAAug 2022Vegzelma, bevacizumab
- PMDASep 2022Bevacizumab BS CTNK, bevacizumab
- FDASep 2022Vegzelma, bevacizumab
- HCJan 2023Vegzelma, bevacizumab
- FDAMay 2023Yuflyma, adalimumab
- PMDASep 2023Adalimumab BS CTNK, adalimumab
- EMAMay 2024Omlyclo, omalizumab
- HCJul 2024Steqeyma, ustekinumab
- EMAAug 2024Steqeyma, ustekinumab
- HCDec 2024Omlyclo, omalizumab
- FDADec 2024Steqeyma, ustekinumab
- FDAJan 2025Avtozma, tocilizumab
- EMAFeb 2025Eydenzelt, aflibercept
- EMAFeb 2025Avtozma, tocilizumab
- EMAFeb 2025Osenvelt, denosumab
- EMAFeb 2025Stoboclo, denosumab
- FDAFeb 2025Osenvelt, denosumab
- FDAFeb 2025Stoboclo, denosumab
- FDAMar 2025Omlyclo, omalizumab
- PMDAMar 2025Ustekinumab BS CT, ustekinumab
- HCSep 2025Osenvelt, denosumab
- HCSep 2025Stoboclo, denosumab
- PMDASep 2025Tocilizumab BS CT, tocilizumab
- FDAOct 2025Eydenzelt, aflibercept
- HCOct 2025Avtozma, tocilizumab
- HCNov 2025Eydenzelt, aflibercept
- PMDAMar 2026Aflibercept BS CT, aflibercept
- PMDAMar 2026Omalizumab BS CT, omalizumab
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