Stelara (ustekinumab) ranks among the highest-grossing biologic drugs in the world, generating over $10 billion in annual U.S. sales for Janssen Pharmaceuticals. A Stelara biosimilar represents a more affordable alternative for patients treating conditions like psoriasis, psoriatic arthritis, and Crohn’s disease. With patent protections expiring and multiple manufacturers pursuing FDA approval, competition is poised to reshape the cost landscape for this widely prescribed biologic.
What Is Stelara and Why Does It Cost So Much?
Stelara is a monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23), two proteins involved in inflammatory and immune responses. The FDA first approved Stelara in September 2009 for moderate-to-severe plaque psoriasis, and subsequent approvals expanded its use to psoriatic arthritis (2013), Crohn’s disease (2016), and ulcerative colitis (2019).
The list price for Stelara exceeds $26,000 per injection, and patients typically require doses every 8 to 12 weeks after an initial loading phase. Annual treatment costs can surpass $80,000 depending on the indication and dosing schedule. These steep prices reflect the complexity of manufacturing biologic drugs, the cost of clinical development, and the market exclusivity Janssen has maintained through an extensive patent portfolio.
Stelara Patent Expiration and Biosimilar Timeline
Janssen’s key patents on Stelara have been the subject of intense litigation. The company’s composition-of-matter patent expired in 2023, but additional patents covering manufacturing processes and specific uses extended protections. Following a series of patent settlements with biosimilar developers, the path to market began opening in 2025.
The FDA approved the first Stelara biosimilar candidates after evaluating extensive analytical, preclinical, and clinical data demonstrating biosimilarity to the reference product. These approvals marked an important milestone for patients who had been paying premium prices for over a decade. Understanding how drug patents work helps explain why biosimilar competition was delayed for so long.
FDA-Approved Stelara Biosimilars
Several pharmaceutical companies have developed biosimilar versions of ustekinumab. Amgen’s biosimilar (ABP 654) and Samsung Bioepis’s candidate are among the products that have progressed through FDA review. Each biosimilar must demonstrate that it is highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency.
The FDA’s approval process for biosimilars involves a rigorous evaluation framework established under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Manufacturers submit data from analytical studies, animal studies, and at least one clinical study demonstrating biosimilarity. For more on how this process works, see our guide on what biosimilars are and how they reach the market.
Interchangeability designations, which allow pharmacists to substitute a biosimilar for the reference product without prescriber intervention, represent an additional regulatory milestone that some Stelara biosimilar developers are pursuing.
How Much Could a Stelara Biosimilar Save You?
Historical data from other biosimilar launches suggests that patients and the healthcare system could see meaningful savings. When biosimilar Humira alternatives entered the market, prices dropped by 30 to 80 percent depending on the payer and distribution channel. Similar dynamics are expected for Stelara biosimilars.
The Congressional Budget Office has estimated that biosimilar competition across all biologic categories could save the U.S. healthcare system over $100 billion in the coming decade. For individual patients, switching to a Stelara biosimilar could reduce out-of-pocket costs by hundreds or even thousands of dollars per year, particularly for those with high-deductible health plans or coinsurance requirements.
Insurance coverage and formulary placement will play a significant role in determining actual savings. Patients should consult their insurance provider and pharmacist to understand how biosimilar options affect their specific cost-sharing obligations. Tools like GoodRx can also help compare prices across pharmacies.
Safety and Efficacy of Stelara Biosimilars
The FDA requires that every approved biosimilar demonstrate no clinically meaningful differences from the reference product in terms of safety, efficacy, and immunogenicity. Clinical trials for Stelara biosimilar candidates have enrolled hundreds of patients across indications like psoriasis, with endpoints measuring treatment response rates, adverse event profiles, and antibody development.
Published data from Phase III studies have shown equivalent clinical response rates between ustekinumab biosimilars and the reference product. Adverse event rates, including injection site reactions and infections, have been comparable across treatment groups. These findings are consistent with the broader biosimilar evidence base, which spans dozens of approved products across multiple therapeutic areas.
The FDA’s post-market surveillance requirements ensure ongoing safety monitoring after approval. Manufacturers must report adverse events, and the FDA can require additional studies if safety signals emerge. This framework provides a robust safety net that has supported biosimilar use for over a decade in the United States.
Switching from Stelara to a Biosimilar
Patients currently receiving Stelara may wonder whether switching to a biosimilar is safe and appropriate. Switching studies, which are often included in the biosimilar clinical development program, evaluate whether patients who transition from the reference product to the biosimilar experience any changes in efficacy or safety.
Data from switching studies across multiple biologic categories have consistently shown that transitioning between reference products and biosimilars does not increase the risk of adverse events, reduced efficacy, or enhanced immunogenicity. Medical societies including the American College of Rheumatology and the American Gastroenterological Association have published positions supporting biosimilar use, including switching in appropriate clinical settings.
Your physician should be involved in any decision to switch treatments. Factors including disease stability, insurance coverage, and individual treatment history all play a role in determining whether a Stelara biosimilar is the right choice for your situation.
How Biosimilars Differ from Generics
Unlike small-molecule generic drugs, biosimilars are not exact copies of their reference products. Biologic drugs are manufactured using living organisms, which introduces inherent variability in the final product. This is why the regulatory pathway for biosimilars is distinct from the Abbreviated New Drug Application (ANDA) process used for traditional generics.
The distinction matters for patients and prescribers because it affects substitution policies, pricing dynamics, and market adoption. For a detailed comparison, our article on biosimilar vs generic differences explains the regulatory and clinical distinctions. Understanding these differences is an important part of navigating the broader landscape of healthcare costs.
Frequently Asked Questions
When will Stelara biosimilars be widely available?
Multiple Stelara biosimilar candidates have received or are pursuing FDA approval, with market availability expanding through 2025 and 2026. Actual availability depends on patent settlement terms, manufacturing readiness, and payer formulary decisions. Check with your pharmacy and insurance plan for the most current information on available options.
Are Stelara biosimilars as effective as the original?
Yes. The FDA requires biosimilars to demonstrate no clinically meaningful differences from the reference product. Clinical trials for Stelara biosimilars have shown equivalent efficacy in treating conditions like plaque psoriasis, with comparable safety profiles. The rigorous approval process ensures that patients can expect similar therapeutic outcomes.
Will my insurance cover a Stelara biosimilar?
Coverage depends on your specific plan and the biosimilar’s formulary placement. Many insurers are incentivized to prefer biosimilars because of their lower cost, and some plans may require step therapy through a biosimilar before covering the reference product. Contact your insurance provider for details about your coverage options. Understanding what a PBM is can also help you navigate formulary decisions.
Can my pharmacist switch me to a Stelara biosimilar automatically?
Automatic substitution at the pharmacy level requires an interchangeability designation from the FDA, along with state-level pharmacy laws that permit biosimilar substitution. Not all Stelara biosimilars may have interchangeability status at launch. Without this designation, your prescriber would need to write a new prescription for the specific biosimilar product.
What This Means for Your Treatment Costs
The arrival of Stelara biosimilar competition represents a significant opportunity for patients, insurers, and the healthcare system to reduce spending on one of the most expensive biologic therapies available. Savings of 30 to 60 percent are realistic based on precedent from other biosimilar categories, and patients should proactively discuss biosimilar options with their physicians and insurance providers. Staying informed about the healthcare policy landscape can help you anticipate changes that affect your access to affordable biologic treatments.