FDA Purple Book · Reference family
penpulimab-kcqx
penpulimab-kcqx is an FDA-licensed reference biologic from Akeso Biopharma Co., Ltd.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
351(a)BLA 761258
Not listed penpulimab-kcqx
Akeso Biopharma Co., Ltd.
- Approved
- Apr 23, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for penpulimab-kcqx, in chronological order.
Reference approval
Approval date of the reference penpulimab-kcqx product.
1 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for penpulimab-kcqx?
No 351(k) biosimilars or interchangeable biosimilars referencing penpulimab-kcqx are listed in the FDA Purple Book yet.
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