Yuflyma

Adalimumab biosimilar developed by Celltrion, development code CT-P17. Reference product Humira.

Brands by market: Yuflyma (USA, EU) · Commercial partner or holder: Celltrion · Company profile

FDAMay 2023approved

EMAFeb 2021authorised

MHRALicenseddate not shown

PMDASep 2023approved

HCDec 2021approved

CDSCONot listed

EDENot listed

Approved or registered in 5 of 7 markets

Connections

Adalimumabmolecule Celltriondeveloper 5 of 7markets 0trials behind it 9other products, same developer 12rival developers in its markets

About Yuflyma

Yuflyma is Celltrion's adalimumab, developed from the start as a high-concentration, citrate-free product. It was approved in Europe in 2021 and in the United States in 2023, and became interchangeable in 2025. In Japan it is approved under the name Adalimumab BS CTNK, marketed by Nippon Kayaku. Celltrion also holds a Canadian approval. It is one of the more widely approved adalimumab biosimilars.

Status by market

FDA

United States · Yuflyma

US Food and Drug AdministrationApproved

Brand

Yuflyma

Holder or applicant

CELLTRION, Inc.

Pathway

351(k)

Approved

May 2023

Application or permission

761219

Licence type

351(k) interchangeable, designated Apr 2025

Reference product in the Purple Book

Humira

Marketing status (Purple Book)

Prescription, marketed

Presentations

10/0.1, 20/0.2, 40/0.4, 80/0.8

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Yuflyma

European Medicines Agency and European CommissionApproved

Brand

Yuflyma

Holder or applicant

Celltrion Healthcare Hungary Kft.

Pathway

Centralised (Article 10(4))

Approved

Feb 2021

Application or permission

EMEA/H/C/005188

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 · Yuflyma

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Yuflyma

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

20 mg, 40 mg and 80 mg syringes; 40 mg and 80 mg pens

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan · Adalimumab BS CTNK

Pharmaceuticals and Medical Devices Agency and MHLWApproved

Brand

Adalimumab BS CTNK

Holder or applicant

Nippon Kayaku (Celltrion)

Pathway

Biosimilar (MHLW approval on PMDA review)

Approved

Sep 2023

Indications as licensed

RA, pJIA, psoriasis, PsA, pustular psoriasis, AS, intestinal Behcet’s, uveitis, Crohn’s disease, UC

Presentations

20 mg/0.2 mL, 40 mg/0.4 mL, 80 mg/0.8 mL syringes; 40 mg and 80 mg pens

Remarks

Adalimumab Biosimilar 4.

Source

S020 (PMDA) · checked Sep 2026

Canada · Yuflyma

Health CanadaApproved

Brand

Yuflyma

Holder or applicant

Celltrion INC.

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Dec 2021

Application or permission

DIN 02523760, 02523779, 02535076, 02535084

Presentations

40, 80 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 Yuflyma holds an approval, these are the other adalimumab biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	9	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Boehringer Ingelheim (Cyltezo), Coherus BioSciences (Yusimry), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
EMA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
MHRA	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Not stated in the MHRA list (Qletli), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)
PMDA	3	Daiichi Sankyo (Adalimumab BS Daiichi Sankyo), Fujifilm Kyowa Kirin Biologics (Hulio), Mochida Pharmaceutical (Adalimumab BS MA)
HC	7	Alvotech (Simlandi / Hukyndra / Libmyris), Amgen (Amjevita / Amgevita), Fresenius Kabi (Idacio), Fujifilm Kyowa Kirin Biologics (Hulio), Pfizer (Abrilada / Amsparity), Samsung Bioepis (Hadlima / Imraldi), Sandoz (Hyrimoz / Hefiya)

Same developer, other molecules

Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Omlyclo, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma.

Chronology

EMAFeb 2021Authorised by the European Commission as Yuflyma
HCDec 2021Notice of Compliance, Health Canada as Yuflyma
FDAMay 2023Approved by FDA as Yuflyma
PMDASep 2023Approved by MHLW as Adalimumab BS CTNK
FDAApr 2025Yuflyma 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)
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All adalimumab biosimilars

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Data current to September 2026.