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FDA Purple Book · Reference family

sarilumab (Kevzara)

sarilumab is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2017

Reference approved

Reference product

351(a)BLA 761037

Kevzara sarilumab

Sanofi-Aventis U.S. LLC

Approved
May 22, 2017
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

Experimental 3D structure for sarilumab from the RCSB Protein Data Bank (PDB 8IOW).

3D molecular structure of sarilumab (PDB entry 8IOW)

Interactive biological assembly from PDB entry 8IOW. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for sarilumab, in chronological order.

  1. Reference approval

    Approval date of the reference sarilumab product.

    9 yr 2 mo ago

Frequently asked questions

Are there biosimilars approved for sarilumab (Kevzara)?

No 351(k) biosimilars or interchangeable biosimilars referencing sarilumab are listed in the FDA Purple Book yet.

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