burosumab-twza (Crysvita)
burosumab-twza is an FDA-licensed reference biologic from Kyowa Kirin, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Crysvita burosumab-twza
Kyowa Kirin, Inc.
- Approved
- Apr 17, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for burosumab-twza, in chronological order.
Reference approval
Approval date of the reference burosumab-twza product.
8 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 mo
Frequently asked questions
Are there biosimilars approved for burosumab-twza (Crysvita)?
No 351(k) biosimilars or interchangeable biosimilars referencing burosumab-twza are listed in the FDA Purple Book yet.
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