FDA Purple Book · Reference family
albiglutide (Tanzeum)
albiglutide 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
2014
Reference approved
Reference product
351(a)BLA 125431
Tanzeum albiglutide
GlaxoSmithKline LLC
- Approved
- Apr 15, 2014
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for albiglutide, in chronological order.
Reference approval
Approval date of the reference albiglutide product.
12 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for albiglutide (Tanzeum)?
No 351(k) biosimilars or interchangeable biosimilars referencing albiglutide are listed in the FDA Purple Book yet.
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