Polpharma Biologics
Biosimilar developer, Poland. 1 development product across 1 molecule: natalizumab.
Portfolio by market
| Molecule | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE | Markets |
|---|---|---|---|---|---|---|---|---|---|
| Natalizumab | Tyruko PB006 | Aug 2023 | Sep 2023 | MHRA | · | · | · | · | 3/7 |
Month shown is the first approval or registration of that product in that market.
Also holds or markets
Products developed by another company for which Polpharma Biologics is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Aflibercept | Eiyzey | EMA | Zaklady Farmaceutyczne Polpharma S.A. | Aug 2025 | Sam Chun Dang Pharm |
| Aflibercept | Vgenfli | EMA | Zaklady Farmaceutyczne Polpharma S.A. | Aug 2025 | Sam Chun Dang Pharm |
In development
ClinicalTrials.gov lists two comparative trials sponsored by Polpharma Biologics for two molecules: natalizumab, vedolizumab. Candidates without an approval yet in the seven markets: PB016.
| Molecule | Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|---|
| Natalizumab | PB006 | Polpharma Biologics | Tysabri | Phase 3 | Comparative efficacy | Completed | Oct 2019 | Aug 2021 | Tyruko | NCT04115488 |
| Vedolizumab | PB016 | Polpharma Biologics | Entyvio | Phase 3 | Comparative efficacy | Unknown, last active, not recruiting | Jul 2023 | Sep 2025 | no approval in the seven markets | NCT05771155 |
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.
Chronology
- FDAAug 2023Tyruko, natalizumab
- EMASep 2023Tyruko, natalizumab
Compare Polpharma Biologics with other developers on the comparison page.
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