المنتج المرجعي للتكافؤ الحيوي · Darbepoetin alfa
| Molecule | Darbepoetin alfa |
|---|---|
| Dosage form | Solution for injection |
| Reference comparator | Aranesp (Amgen) |
| Tier | A |
| Recommended BE approach | Totality-of-evidence comparability: analytical + functional, PK/PD ± clinical — WHO TRS 1043 Annex 3 |
| Note | Biological — comparability exercise |
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Cite as: AUPAM Experts' Office, Darbepoetin alfa (Solution for injection) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/darbepoetin-alfa-s338.html