belimumab (Benlysta)
belimumab 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
2011
Reference approved
Reference product
Benlysta belimumab
GlaxoSmithKline LLC
- Approved
- Mar 09, 2011
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for belimumab from the RCSB Protein Data Bank (PDB 5Y9K).
Interactive biological assembly from PDB entry 5Y9K. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for belimumab, in chronological order.
Reference approval
Approval date of the reference belimumab product.
15 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for belimumab (Benlysta)?
No 351(k) biosimilars or interchangeable biosimilars referencing belimumab 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.