tositumomab and iodine I-131 tositumomab (Bexxar)
tositumomab and iodine I-131 tositumomab 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
2003
Reference approved
Reference product
Bexxar tositumomab and iodine I-131 tositumomab
GlaxoSmithKline LLC
- Approved
- Jun 27, 2003
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tositumomab and iodine I-131 tositumomab, in chronological order.
Reference approval
Approval date of the reference tositumomab and iodine I-131 tositumomab product.
23 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for tositumomab and iodine I-131 tositumomab (Bexxar)?
No 351(k) biosimilars or interchangeable biosimilars referencing tositumomab and iodine I-131 tositumomab are listed in the FDA Purple Book yet.
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