avelumab (Bavencio)
avelumab is an FDA-licensed reference biologic from EMD Serono, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Bavencio avelumab
EMD Serono, Inc.
- Approved
- Mar 23, 2017
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for avelumab from the RCSB Protein Data Bank (PDB 5GRJ).
Interactive biological assembly from PDB entry 5GRJ. 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 avelumab, in chronological order.
Reference approval
Approval date of the reference avelumab product.
9 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
2 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for avelumab (Bavencio)?
No 351(k) biosimilars or interchangeable biosimilars referencing avelumab 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.