Abrilada / Amsparity
Adalimumab biosimilar developed by Pfizer, development code PF-06410293. Reference product Humira.
Brands by market: Abrilada (USA); Amsparity (EU) · Commercial partner or holder: Pfizer
FDANov 2019approved
EMAFeb 2020authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Abrilada
US Food and Drug AdministrationApprovedBrand
Abrilada
Holder or applicant
Pfizer Inc.
Pathway
351(k)
Approved
Nov 2019
Application or permission
761118
Licence type
351(k) interchangeable, designated Oct 2023
Presentations
10/0.2, 20/0.4, 40/0.8
Source
S001, S016
EMA
European Union · Amsparity
European Medicines Agency and European CommissionApprovedBrand
Amsparity
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Feb 2020
Application or permission
EMEA/H/C/004879
Indications as licensed
RA, JIA, axSpA, PsA, psoriasis, HS, Crohn's disease, UC, uveitis
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDANov 2019Approved by FDA as Abrilada
- EMAFeb 2020Authorised by the European Commission as Amsparity
- FDAOct 2023Abrilada designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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