Avsola
Infliximab biosimilar developed by Amgen, development code ABP 710. Reference product Remicade.
Brands by market: Avsola (USA) · Commercial partner or holder: Amgen
FDADec 2019approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Avsola
US Food and Drug AdministrationApprovedBrand
Avsola
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Dec 2019
Application or permission
761086
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg vial
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDADec 2019Approved by FDA
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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