Drugs / FYB206
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT06551064 | Jul 2024 → Jun 2026 overdue | melanoma | Formycon AG | Active not recruiting | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06643117 | Oct 2024 → May 2025 | non-small cell lung carcinoma | Formycon AG | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-02-27 | Zydus Lifesciences Limited | Results Zydus Lifesciences announces successful clinical development of Pembrolizumab biosimilar FYB206, marking a milestone toward USFDA filing zyduslife.com ↗
The randomized, double-blind, multi-centre clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda ®. |
| 2026-02-25 | Formycon AG | Results Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab) formycon.com ↗
The randomized, double-blind, multicenter clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda ®1 . |
| 2024-10-16 | Formycon AG | Results Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D formycon.com ↗
The paper indicates that FYB206 is structurally and functionally highly similar to the reference product, thereby supporting the testing of the proposed pembrolizumab biosimilar in clinical trials to confirm the similarity between the two products. |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FYB206 | “FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year...” NCT06643117 ↗ |
| Modality | Protein / enzyme biologic | “FYB206 is a proposed biosimilar to Keytruda. A biosimilar is not identical but very similar to its original biologic.” NCT06551064 ↗ |
| Route | Intravenous | “administered as an IV infusion” NCT06551064 ↗ |