Home/Biosimilar Atlas/Adalimumab/Abrilada / Amsparity

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 · Company profile
FDANov 2019approved
EMAFeb 2020authorised
MHRANot listed
PMDANot listed
HCJan 2021approved
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
AdalimumabmoleculePfizerdeveloper3 of 7markets0trials behind it6other products, same developer9rival developers in its markets

About Abrilada / Amsparity

Abrilada is Pfizer's adalimumab, approved in the United States in 2019 and in Europe, as Amsparity, in 2020. Pfizer chose not to launch Amsparity in Europe. In the United States it launched in 2023 with the other adalimumab biosimilars and became interchangeable later that year. Pfizer also filed a second European name, Fyzoclad, which it withdrew before assessment.

Status by market

FDA

United States · Abrilada

US Food and Drug AdministrationApproved
Brand
Abrilada
Holder or applicant
Pfizer Inc.
Pathway
351(k)
Approved
Nov 2019
Application or permission
761118
Licence type
351(k) interchangeable, designated Oct 2023
Reference product in the Purple Book
Humira
Marketing status (Purple Book)
Prescription; some presentations discontinued
Presentations
10/0.2, 20/0.4, 40/0.8
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Amsparity

European Medicines Agency and European CommissionApproved
Brand
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 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada · Abrilada

Health CanadaApproved
Brand
Abrilada
Holder or applicant
Pfizer Canada ULC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jan 2021
Application or permission
DIN 02511045, 02511053, 02511061
Presentations
20, 40 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Abrilada / Amsparity holds an approval, these are the other adalimumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA9Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Boehringer Ingelheim (Cyltezo), Celltrion (Yuflyma), Coherus BioSciences (Yusimry), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EMA7Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
HC7Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Celltrion (Yuflyma), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)

Same developer, other molecules

Other biosimilars in the Atlas developed by Pfizer: Ixifi / Zessly, Nivestym / Nivestim, Nyvepria, Ruxience, Trazimera, Zirabev.

Chronology

Sources

All adalimumab biosimilars

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Data current to September 2026.