What is Steqeyma in the FDA Purple Book?

Steqeyma, BLA 761338, is listed as a 351(k) interchangeable biosimilar with 4 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 761338?

Steqeyma, BLA 761338, lists CELLTRION, Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Steqeyma?

Steqeyma, BLA 761338, has 4 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Steqeyma's reference-product relationship?

Steqeyma, BLA 761338, lists Stelara as its FDA reference product. The loaded row does not supply a reference BLA number, so this page does not invent one from a name match.

When was Steqeyma licensed by FDA?

Steqeyma, BLA 761338, has a listed FDA approval date of Dec 17, 2024. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Steqeyma's FDA label?

Steqeyma, BLA 761338, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Steqeyma?

Steqeyma, BLA 761338, has 12 published Purple Book patent rows, with the latest listed expiration on Sep 24, 2039. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Steqeyma?

Steqeyma, BLA 761338, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · Interchangeable

Steqeyma

ustekinumab-stba

Steqeyma, BLA 761338, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 4 exact FDA presentation rows, and FDA names Stelara as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) InterchangeableBLA 761338 4 presentationsRxLicensed CELLTRION, Inc.

Approved

Dec 17, 2024

License type

351(k) Interchangeable

Marketing

Listed patents

Steqeyma (ustekinumab-stba) is a Interchangeable referencing ustekinumab, licensed under a 351(k) BLA in 2024; the Purple Book lists CELLTRION, Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. Its interchangeable biosimilar designation may permit pharmacy-level substitution for the reference product without prescriber intervention, subject to state law; it is not a superiority claim. The Purple Book lists 12 published patents for this product.

Sourced from the FDA Purple Book · verified Sep 21, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

761338

Regulatory role

351(k) interchangeable biosimilar

Applicant

CELLTRION, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Dec 17, 2024

Reference product

Stelara

Steqeyma is an FDA-designated interchangeable biosimilar.

Steqeyma is a 351(k) biosimilar of Stelara and carries an interchangeability designation.

Substitution boundary

An interchangeable designation may permit pharmacy-level substitution for the reference product without prescriber intervention, depending on state pharmacy law; it is not a claim of clinical superiority.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Dec 17, 2024
1 yr 9 mo ago
Today

Strengths & presentations

4 FDA presentation rows · BLA 761338

Strength

45MG/0.5ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1996

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	45MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
002	90MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
003	130MG/26ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Licensed	Rx
004	45MG/0.5ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

Steqeyma names Stelara as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Stelara

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Stelaraustekinumab	351(a) ambiguous reference candidate	125261	Sep 25, 2009	45MG/0.5ML · Subcutaneous	Rx
Stelaraustekinumab	351(a) ambiguous reference candidate	761044	Sep 23, 2016	130MG/26ML (5MG/ML) · Intravenous	Rx
Steqeymaustekinumab-stba	351(k) interchangeable biosimilar	761338	Dec 17, 2024	45MG/0.5ML · Subcutaneous	Rx

Published patents

BPCIA patent list

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
6,902,734	Sep 25, 2023	3 yr ago	FDA
6,902,734	Sep 25, 2023	3 yr ago	FDA
8,852,889	Jul 06, 2032	in 5 yr 10 mo	FDA
8,852,889	Jul 06, 2032	in 5 yr 10 mo	FDA
9,475,858	Jul 06, 2032	in 5 yr 10 mo	FDA
9,475,858	Jul 06, 2032	in 5 yr 10 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 7 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 7 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 7 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 7 mo	FDA
10,961,307	Sep 24, 2039	in 13 yr 2 mo	FDA
10,961,307	Sep 24, 2039	in 13 yr 2 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

4 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Subcutaneous and Intravenous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

CELLTRION, Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Steqeyma is an FDA-designated interchangeable biosimilar. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Sep 21, 2026

FDA release · August 2026

FDA source FDA source

monthly-downloadMonthly download · Sep 21, 2026
advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v6Sep 21, 2026
v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Steqeyma: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo