FDA Purple Book · Reference family
cemiplimab-rwlc (Libtayo)
cemiplimab-rwlc is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, 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
351(a)BLA 761097
Libtayo cemiplimab-rwlc
Regeneron Pharmaceuticals, Inc.
- Approved
- Sep 28, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for cemiplimab-rwlc, in chronological order.
Reference approval
Approval date of the reference cemiplimab-rwlc product.
7 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for cemiplimab-rwlc (Libtayo)?
No 351(k) biosimilars or interchangeable biosimilars referencing cemiplimab-rwlc are listed in the FDA Purple Book yet.
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