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Purple Book reference family · 351(a) biologic

avelumab (Bavencio)

avelumab is an FDA-licensed reference biologic from EMD Serono, Inc..

351(a) biologicBLA 761049 EMD Serono, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017

Reference product

Originator biologic
351(a)BLA 761049

Bavencio avelumab

EMD Serono, Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for avelumab from the RCSB Protein Data Bank (PDB 5GRJ).

3D molecular structure of avelumab (PDB entry 5GRJ)

Interactive biological assembly from PDB entry 5GRJ. 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
  1. Reference approval

    Approval date of the reference avelumab product.

    9 yr 8 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    2 yr 6 mo ago

avelumab: 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 avelumab.

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Agent CTA Background

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