tislelizumab-jsgr (Tevimbra)
tislelizumab-jsgr is an FDA-licensed reference biologic from BeiGene USA, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Tevimbra tislelizumab-jsgr
BeiGene USA, Inc.
- Approved
- Mar 13, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tislelizumab-jsgr, in chronological order.
Reference approval
Approval date of the reference tislelizumab-jsgr product.
2 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 10 mo
Frequently asked questions
Are there biosimilars approved for tislelizumab-jsgr (Tevimbra)?
No 351(k) biosimilars or interchangeable biosimilars referencing tislelizumab-jsgr are listed in the FDA Purple Book yet.
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