FDA Purple Book · Reference family
anifrolumab-fnia (Saphnelo)
anifrolumab-fnia is an FDA-licensed reference biologic from AstraZeneca AB. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2026
Reference approved
Reference product
351(a)BLA 761451
Saphnelo anifrolumab-fnia
AstraZeneca AB
- Approved
- Apr 24, 2026
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for anifrolumab-fnia, in chronological order.
Reference approval
Approval date of the reference anifrolumab-fnia product.
1 mo ago
Frequently asked questions
Are there biosimilars approved for anifrolumab-fnia (Saphnelo)?
No 351(k) biosimilars or interchangeable biosimilars referencing anifrolumab-fnia are listed in the FDA Purple Book yet.
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