Avsola
Infliximab biosimilar developed by Amgen, development code ABP 710. Reference product Remicade.
About Avsola
Avsola is Amgen's infliximab, approved in the United States in December 2019 and in Canada in 2020. It was the fourth and last infliximab biosimilar in the United States. Amgen has not filed it in Europe.
Status by market
United States · Avsola
US Food and Drug AdministrationApprovedEuropean Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada · Avsola
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Avsola holds an approval, these are the other infliximab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 3 | Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly), Samsung Bioepis (Renflexis / Flixabi) |
| HC | 3 | Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly), Samsung Bioepis (Renflexis / Flixabi) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Bkemv / Bekemv, Kanjinti, Mvasi, Pavblu, Riabni, Wezlana / Wezenla.
Chronology
- FDADec 2019Approved by FDA as Avsola
- HCMar 2020Notice of Compliance, Health Canada as Avsola
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
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