FDA Purple Book · Reference family
glofitamab-gxbm (Columvi)
glofitamab-gxbm is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
351(a)BLA 761309
Columvi glofitamab-gxbm
Genentech, Inc.
- Approved
- Jun 15, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for glofitamab-gxbm, in chronological order.
Reference approval
Approval date of the reference glofitamab-gxbm product.
3 yr ago
Frequently asked questions
Are there biosimilars approved for glofitamab-gxbm (Columvi)?
No 351(k) biosimilars or interchangeable biosimilars referencing glofitamab-gxbm are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.