Purple Book reference family · 351(a) biologic
sarilumab (Kevzara)
sarilumab is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC.
351(a) biologicBLA 761037 Sanofi-Aventis U.S. LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017
Reference product
Originator biologic
351(a)BLA 761037
Kevzara sarilumab
Sanofi-Aventis U.S. LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
RCSB Protein Data Bank
Experimental 3D structure for sarilumab from the RCSB Protein Data Bank (PDB 8IOW).
Interactive biological assembly from PDB entry 8IOW. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference sarilumab product.
9 yr 6 mo ago
sarilumab: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for sarilumab.
Related FDA reference tools
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- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
