immune globulin intravenous, human-stwk (Alyglo)
immune globulin intravenous, human-stwk is an FDA-licensed reference biologic from GC Biopharma Corp.. 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
Alyglo immune globulin intravenous, human-stwk
GC Biopharma Corp.
- Approved
- Dec 15, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for immune globulin intravenous, human-stwk, in chronological order.
Reference approval
Approval date of the reference immune globulin intravenous, human-stwk product.
2 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for immune globulin intravenous, human-stwk (Alyglo)?
No 351(k) biosimilars or interchangeable biosimilars referencing immune globulin intravenous, human-stwk are listed in the FDA Purple Book yet.
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