Fujifilm Kyowa Kirin Biologics
Biosimilar developer, Japan. 1 development product across 1 molecule: adalimumab.
Portfolio by market
| Molecule | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE | Markets |
|---|---|---|---|---|---|---|---|---|---|
| Adalimumab | Hulio FKB327 | Jul 2020 | Sep 2018 | MHRA | Jun 2020 | Nov 2020 | ยท | May 2025 | 6/7 |
Month shown is the first approval or registration of that product in that market.
In development
ClinicalTrials.gov lists one comparative trial sponsored by Fujifilm Kyowa Kirin Biologics for one molecule: adalimumab. 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Adalimumab | FKB327 | Fujifilm Kyowa Kirin Biologics | Humira | Phase 3 | Comparative efficacy | Completed | Jun 2015 | Jan 2018 | Hulio | NCT02405780 |
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 Fujifilm Kyowa Kirin Biologics, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.
Chronology
- EMASep 2018Hulio, adalimumab
- PMDAJun 2020Adalimumab BS FKB, adalimumab
- FDAJul 2020Hulio, adalimumab
- HCNov 2020Hulio, adalimumab
- EDEMay 2025Hulio, adalimumab
Compare Fujifilm Kyowa Kirin Biologics with other developers on the comparison page.
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