Last reviewed 2026-05-25 · How we verify

YUFLYMA (ADALIMUMAB-AATY)

CELLTRION · FDA-approved approved ✓ Verified May 2026

YUFLYMA (generic name: ADALIMUMAB-AATY) is a drug developed by CELLTRION. It is currently FDA-approved.

Yuflyma is a biosimilar of adalimumab, a tumor necrosis factor-alpha inhibitor used to treat conditions such as rheumatoid arthritis, ankylosing spondylarthritis, and psoriatic arthritis. It is administered in a high concentration, low volume formulation of 40mg/0.4mL.

At a glance

Generic name	ADALIMUMAB-AATY
Sponsor	CELLTRION
Therapeutic area	Other
Phase	FDA-approved

Approved indications

No approved indications tracked.

Boxed warnings

WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUFLYMA if a patient develops a serious infection or sepsis during treatment. Pe

Common side effects

Injection site reactions
Infections (upper respiratory, sinusitis)
Headache
Rash
Positive ANA titers
ALT elevations ≥ 3 × ULN

Serious adverse events

Serious infections
Pneumonia
Active tuberculosis
Serious opportunistic infections
Lupus-like syndrome
Acute liver failure
Septic arthritis
Cellulitis
Diverticulitis
Pyelonephritis

Key clinical trials

YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU (N/A)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

YUFLYMA CI brief — competitive landscape report
YUFLYMA updates RSS · CI watch RSS
CELLTRION portfolio CI

Frequently asked questions about YUFLYMA

What is YUFLYMA?

YUFLYMA (ADALIMUMAB-AATY) is a pharmaceutical drug developed by CELLTRION.

Who makes YUFLYMA?

YUFLYMA is developed and marketed by CELLTRION (see full CELLTRION pipeline at /company/celltrion).

What is the generic name of YUFLYMA?

ADALIMUMAB-AATY is the generic (nonproprietary) name of YUFLYMA.

What development phase is YUFLYMA in?

YUFLYMA is FDA-approved (marketed).

What are the side effects of YUFLYMA?

Common side effects of YUFLYMA include Injection site reactions, Infections (upper respiratory, sinusitis), Headache, Rash, Positive ANA titers, ALT elevations ≥ 3 × ULN. Serious adverse events: Serious infections, Pneumonia, Active tuberculosis, Serious opportunistic infections.

Manufacturer: CELLTRION — full pipeline
Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing