FDA Purple Book · Reference family
dostarlimab-gxly (Jemperli)
dostarlimab-gxly is an FDA-licensed reference biologic from GlaxoSmithKline LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
351(a)BLA 761174
Jemperli dostarlimab-gxly
GlaxoSmithKline LLC
- Approved
- Apr 22, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for dostarlimab-gxly, in chronological order.
Reference approval
Approval date of the reference dostarlimab-gxly product.
5 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for dostarlimab-gxly (Jemperli)?
No 351(k) biosimilars or interchangeable biosimilars referencing dostarlimab-gxly are listed in the FDA Purple Book yet.
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