velmanase alfa-tycv (Lamzede)
velmanase alfa-tycv is an FDA-licensed reference biologic from Chiesi Farmaceutici S.p.A.. 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
Lamzede velmanase alfa-tycv
Chiesi Farmaceutici S.p.A.
- Approved
- Feb 16, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for velmanase alfa-tycv, in chronological order.
Reference approval
Approval date of the reference velmanase alfa-tycv product.
3 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 9 mo
Frequently asked questions
Are there biosimilars approved for velmanase alfa-tycv (Lamzede)?
No 351(k) biosimilars or interchangeable biosimilars referencing velmanase alfa-tycv are listed in the FDA Purple Book yet.
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