Last reviewed 2026-05-21 · How we verify

STEQEYMA (USTEKINUMAB-STBA)

CELLTRION, INC. · FDA-approved approved Under review Quality 10/100

STEQEYMA (generic name: USTEKINUMAB-STBA) is a Interleukin-12 Antagonist [EPC] drug developed by CELLTRION, INC.. It is currently FDA-approved.

Ustekinumab binds to the p40 subunit of IL-12 and IL-23, disrupting their signaling and reducing inflammation.

SteQeyma is a ustekinumab biosimilar used to treat Crohn's disease and plaque psoriasis, and it works by inhibiting interleukin-12. It is an antibody-based inhibitor that is administered in doses of 45 mg or 90 mg.

At a glance

Generic name	USTEKINUMAB-STBA
Sponsor	CELLTRION, INC.
Drug class	Interleukin-12 Antagonist [EPC]
Target	p40 protein subunit of IL-12 and IL-23
Therapeutic area	Other
Phase	FDA-approved

Mechanism of action

Ustekinumab is a monoclonal antibody that targets the p40 protein subunit of the cytokines IL-12 and IL-23. By binding to this subunit, ustekinumab prevents these cytokines from interacting with their receptors, thereby blocking the inflammatory signals they normally transmit. This helps reduce the chronic inflammation seen in conditions like Crohn's disease and ulcerative colitis.

Approved indications

No approved indications tracked.

Common side effects

nasopharyngitis
upper respiratory tract infection
headache
fatigue
back pain
dizziness
pharyngolaryngeal pain
pruritus
injection site erythema
myalgia
depression

Drug interactions

immunosuppressive agents
phototherapy
methotrexate (MTX)
6-mercaptopurine (6-MP), azathioprine (AZA)
corticosteroids
CYP450 substrates
allergen immunotherapy

Key clinical trials

ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab (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:

STEQEYMA CI brief — competitive landscape report
STEQEYMA updates RSS · CI watch RSS
CELLTRION, INC. portfolio CI

Frequently asked questions about STEQEYMA

What is STEQEYMA?

STEQEYMA (USTEKINUMAB-STBA) is a Interleukin-12 Antagonist [EPC] drug developed by CELLTRION, INC..

How does STEQEYMA work?

Ustekinumab binds to the p40 subunit of IL-12 and IL-23, disrupting their signaling and reducing inflammation.

Who makes STEQEYMA?

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

What is the generic name of STEQEYMA?

USTEKINUMAB-STBA is the generic (nonproprietary) name of STEQEYMA.

What drug class is STEQEYMA in?

STEQEYMA belongs to the Interleukin-12 Antagonist [EPC] class. See all Interleukin-12 Antagonist [EPC] drugs at /class/interleukin-12-antagonist-epc.

What development phase is STEQEYMA in?

STEQEYMA is FDA-approved (marketed).

What are the side effects of STEQEYMA?

Common side effects of STEQEYMA include nasopharyngitis, upper respiratory tract infection, headache, fatigue, back pain, dizziness.

What does STEQEYMA target?

STEQEYMA targets p40 protein subunit of IL-12 and IL-23 and is a Interleukin-12 Antagonist [EPC].

Drug class: All Interleukin-12 Antagonist [EPC] drugs
Target: All drugs targeting p40 protein subunit of IL-12 and IL-23
Manufacturer: CELLTRION, INC. — full pipeline
Therapeutic area: All drugs in Other