About Ustekinumab

Ustekinumab Is an Unbranded Biologic, Not a Biosimilar

Unbranded Biologic1,2

Same product as the brand-name biologic* without the brand name, marketed under the same BLA

Produced using the same cell line as the brand-name biologic1,2*

Brand-Name Biologic3,4*

Approved in a stand-alone BLA that demonstrates the product's safety and effectiveness

Produced through biotechnology in a living system (ie, a “cell line”)4

Biosimilar5†

Highly similar to brand-name biologic* with no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness)

May be produced using the same or a different cell line6

Ustekinumab: An Unbranded Biologic Treatment Option
for Patients Prescribed STELARA®
(ustekinumab)

An unbranded biologic is1:

An approved brand-name biologic* being marketed under its approved biologics license without the brand name

Considered by the FDA to be the same product as the brand-name biologic* under the same biologics license

The same strengths, dosage forms, presentations, and routes of administration as the brand-name biologic*

*"Brand-name" biologic refers to the FDA-approved reference biologic.
†During the approval process, the FDA conducts a thorough evaluation that ensures that all biosimilars, including interchangeable biosimilars, are as safe and effective as their reference product and meet the FDA's high standards for approval.5

BLA, biologics license application; FDA, U.S. Food and Drug Administration.

Ustekinumab Is STELARA® (ustekinumab) Without the Brand Name1,7,8

Produced from the same
cell line and at the same manufacturing sites as STELARA®

Approved for all the same indications as STELARA® with the same safety and efficacy profile

Available in the same strengths, same dosage forms, and same routes of administration as STELARA®

Has many of the same patient support resources as STELARA®

Ustekinumab Is Priced Lower Than Branded STELARA®, Based on Wholesale Acquisition Cost9

Ustekinumab builds on the 20+ years of
clinical experience of STELARA®2

Over 630,000 Patients Are Estimated to Have Been Treated With STELARA® for Crohn’s Disease or Other Approved Indications in the United States2‡

‡Based on information licensed from IQVIA: LAAD claims for the period of 2009-2023 reflecting estimates of real-world activity and based on custom methodologies developed by Johnson & Johnson.2
§A phase 1 clinical trial of STELARA® was initiated in 2001 in patients with moderate to severe plaque psoriasis. Phase 3, double-blind, placebo-controlled, multicenter trials PHOENIX 1 and PHOENIX 2 began in 2005 and 2006, respectively.2


LAAD, Longitudinal Access and Adjudication Data.

References: 1. U.S. Food and Drug Administration. FAQs–Purple Book. Accessed February 27, 2025. https://purplebooksearch.fda.gov/faqs 2. Data on file. Janssen Biotech, Inc. 3. U.S. Food and Drug Administration. Review and Approval. Accessed December 10, 2024. https://www.fda.gov/drugs/biosimilars/review-and-approval 4. Declerck P, Farouk-Rezk M, Rudd PM. Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res. 2016;33(2):261-268. doi:10.1007/s11095-015-1790-3 5. U.S. Food and Drug Administration. Biological Product Definitions. Accessed April 1, 2025. 6. U.S. Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Published April 2015. Accessed January 23, 2025. https://www.fda.gov/media/82647/download 7. Ustekinumab [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 8. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 9. AnalySource®. Accessed February 20, 2025. https://www.analysource.com/