Purple Book reference family · 351(a) biologic
rebisufligene etisparvovec-hopf (Fayuvi)
rebisufligene etisparvovec-hopf is an FDA-licensed reference biologic from Ultragenyx Pharmaceutical Inc..
351(a) biologicBLA 125845 Ultragenyx Pharmaceutical Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 125845
Fayuvi rebisufligene etisparvovec-hopf
Ultragenyx Pharmaceutical Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference rebisufligene etisparvovec-hopf product.
24 d ago
rebisufligene etisparvovec-hopf: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
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