Ustekinumab Biosimilars Market - Global Forecast 2026-2032

The Ustekinumab Biosimilars Market size was estimated at USD 1.74 billion in 2025 and expected to reach USD 2.00 billion in 2026, at a CAGR of 14.61% to reach USD 4.53 billion by 2032.

The expiration of the primary composition-of-matter patent for Stelara in September 2023 marked a profound inflection point in immunology therapeutics, catalyzing the entry of biosimilar candidates into a market that had been safeguarded by exclusivity since the mid-2000s. Ustekinumab, the active monoclonal antibody behind Stelara, has long been a cornerstone treatment across a spectrum of immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.9 The settlement agreements between Johnson & Johnson and multiple biosimilar developers set the stage for a staggered launch schedule beginning in early 2025, transforming the competitive landscape and offering payers and providers alternative options to the originator product.10 This confluence of patent cliffs and settlement timelines underscores the strategic urgency among stakeholders to prepare for a surge of high-quality, lower-cost substitutes.

As biosimilars promise to uphold the reference product’s rigorous safety and efficacy profile while delivering significant cost advantages, market access strategies will hinge on demonstrating interchangeability, fostering provider confidence, and navigating diverse substitution laws. The FDA’s interchangeable designation for Wezlana (Amgen) and provisional interchangeability for other entrants such as Otulfi (Fresenius Kabi and Formycon) and SELARSDI (Teva and Alvotech) have provided an additional lever for rapid uptake at the pharmacy level.0 These regulatory milestones highlight the evolving framework within which manufacturers must orchestrate education, real-world evidence generation, and payer negotiations to secure formulary placement and optimal reimbursement pathways.

The rapid succession of approvals and launches for Ustekinumab biosimilars in early 2025 has redefined the competitive dynamics of immunology care. Within the first quarter of the year, multiple developers transitioned from pipeline prospects to commercial rivals, challenging the market incumbency of Stelara. Amgen’s Wezlana achieved the distinction of the first interchangeable biosimilar with a January 1, 2025 launch, while Teva and Alvotech’s SELARSDI and Fresenius Kabi and Formycon’s Otulfi followed closely, each securing provisional interchangeability determinations from the FDA4,0 These milestones have underscored payers’ growing appetite for biosimilar adoption in both public and private formularies, amplifying cost-containment initiatives across the healthcare ecosystem.

Concurrently, entrenched strategies have emerged as frontrunners vie for advantageous contracting terms with pharmacy benefit managers and integrated delivery networks. Manufacturers are leveraging steep launch discounts-reported between 80% and 90% off the reference list price-to incentivize uptake, yet actual net pricing will be contingent on rebate negotiations and volume commitments with the ‘Big Three’ PBMs.3 This aggressive market entry has not only intensified competitive pressure on Janssen’s pricing power but has also underscored the importance of differentiated patient support services, real-world switching data, and advanced patient engagement platforms as critical enablers of biosimilar penetration. The landscape is now defined by a confluence of regulatory finesse, supply chain optimization, and strategic alliances, all of which will dictate the winners and losers in this burgeoning segment.

In 2025, the United States instituted a blanket 10% tariff on nearly all imported goods, encompassing active pharmaceutical ingredients and critical drug intermediates, with additional specific duties reaching up to 25% for APIs sourced from China and India.0 This sweeping measure, although aimed at fostering domestic production, has precipitated immediate cost escalations for biosimilar manufacturers reliant on global supply chains. While finished biopharmaceuticals have been initially exempted, ancillary inputs such as sterile vials, analytical instrumentation, and packaging components now attract substantial levies, driving operational expenses upward and complicating the economics of biosimilar production4.

Anticipating potential escalations to tariffs as high as 200% under forthcoming policy proposals, leading biopharma companies are re-evaluating their sourcing strategies and accelerating investments in U.S.-based manufacturing capabilities. Biogen’s announcement of a $2 billion expansion in North Carolina, alongside AstraZeneca’s planned $50 billion commitment to domestic facilities by 2030, exemplifies the sector’s pivot toward onshore resilience to mitigate future trade risks.13 These capital allocations underscore a strategic reshoring imperative, balancing short-term cost inflation against long-term supply security. As regulatory authorities contemplate further reciprocal tariffs, biosimilar developers must navigate a fluid policy environment, securing tariff exemptions where possible while reinforcing their domestic footprint to safeguard uninterrupted patient access.

The Ustekinumab biosimilars market is dissected across multiple analytical dimensions to capture the breadth and depth of product differentiation and patient needs. Based on indication, the market spans Crohn disease with its subtypes of colonic, ileal, and ileocolonic presentations; plaque psoriasis categorized into moderate and severe cohorts; psoriatic arthritis sub-phenotypes including asymmetric, spondylitis, and symmetric patterns; and ulcerative colitis in its left-sided, pancolitis, and proctitis forms. This granular understanding of disease heterogeneity informs dosing regimens, efficacy benchmarks, and real-world utilization studies. Concurrently, dosage form segmentation evaluates patient preferences and adherence considerations across autoinjectors, prefilled syringes, and vial presentations, each offering distinct handling and administration attributes. Strength parameters further refine market analysis, distinguishing between the 45 mg and 90 mg formulations that align with induction and maintenance therapy protocols.

Distribution channel dynamics highlight variances in procurement, as hospital pharmacies, online platforms, and retail outlets serve divergent patient populations and logistical models. The interplay between channel selection and reimbursement pathways influences formulary access and price realization. Finally, end-user segmentation across home care settings, hospital administrations, and specialty clinics underscores the critical role of site-of-care economics, therapeutic support services, and provider expertise in shaping adoption rates. By synthesizing these segmentation lenses, industry stakeholders can architect targeted commercialization strategies, optimize channel mix, and tailor value propositions to key decision-makers.

Regional market dynamics for Ustekinumab biosimilars reveal distinct regulatory, economic, and healthcare infrastructure influences in the Americas, Europe, Middle East & Africa, and Asia-Pacific. In North America, the United States has emerged as the epicenter of biosimilar activity, driven by substantial payer incentives, well-established regulatory pathways for interchangeability, and early settlement-driven launch schedules that have delivered both Amgen’s Wezlana and Teva’s SELARSDI. The robust adoption environment is characterized by streamlined pharmacy substitution policies in many states and aggressive cost containment mandates from public and private payers.

Within Europe, the regulatory harmonization afforded by the European Medicines Agency has facilitated cross-border approvals, yet national reimbursement decisions introduce variability in biosimilar uptake. First-mover advantage has been realized by entrants such as Uzpruvo (Alvotech/Stada), which capitalized on patent expiries in early 2024 to establish clinical trust and formulary access across leading markets in Germany, the United Kingdom, and France. In contrast, emerging markets within the Middle East and Africa are navigating infrastructure constraints and funding limitations, although multinational partnerships are enhancing distribution capacity and patient support frameworks.

The Asia-Pacific region is poised to deliver the fastest uptake growth, buoyed by escalating healthcare expenditure, expanding biologics manufacturing capabilities, and policy initiatives aimed at improving access to advanced therapies. Countries such as China, India, and Japan have witnessed strategic alliances-like Biocon’s out-licensing agreements-that have accelerated local biosimilar development and commercialization, strengthening supply chains and reducing time to market. These regional nuances underscore the imperative for tailored market entry strategies that align regulatory engagements, pricing models, and stakeholder advocacy across heterogeneous healthcare ecosystems.

Leading biosimilar developers have marshaled differentiated strategies to secure a foothold in the Ustekinumab biosimilar segment. Amgen leveraged an early settlement with Johnson & Johnson to launch Wezlana as the first interchangeable biosimilar, coupling that regulatory edge with robust phase 3 switching data and a network of specialty pharmacy partnerships to expedite adoption. Fresenius Kabi and Formycon advanced Otulfi with both subcutaneous and intravenous formulations, emphasizing manufacturing scale and a provisional interchangeability determination to appeal to hospital systems and infusion centers. Teva and Alvotech’s SELARSDI strategy combined cost-effective licensing with Teva’s extensive commercial infrastructure to negotiate favorable PBM contracts and leverage global supply chain synergies.

Samsung Bioepis and Sandoz introduced Pyzchiva with an aggressive price point and a focus on digital patient engagement platforms, while Celltrion’s Steqeyma emphasized sustainability in manufacturing, highlighting renewable energy-powered production facilities. Biocon’s Yesintek capitalized on an early CHMP positive opinion and diversified presentations to target both adult and pediatric indications. Accord’s Imuldosa, poised for a mid-2025 launch, has underscored its quality systems accreditation and multi-country licensing agreements to reassure payers of continuity and supply reliability. Together, these competitive moves reflect a market where regulatory designations, manufacturing excellence, commercial alliances, and technology-driven patient support converge to define leadership.

Industry leaders should prioritize establishing robust evidence packages that not only confirm biosimilarity but also demonstrate seamless switching outcomes and long-term safety through real-world data analytics. By partnering with healthcare systems and leveraging electronic health record networks, manufacturers can generate compelling post-launch evidence that accelerates formulary inclusion and supports payer negotiations. Additionally, aligning with key pharmacy benefit managers early to structure value-based contracting arrangements will be critical in securing preferred placement within cost-sensitive formularies.

To mitigate tariff exposure and ensure supply chain resilience, companies should evaluate co-manufacturing partnerships in the United States and diversify sourcing of critical biologics components. Investing in modular, flexible production technologies and automation can reduce lead times and buffer against policy-driven disruptions. Furthermore, differentiating product offerings through enhanced patient support programs-including specialty nursing services, adherence tracking tools, and digital education platforms-will serve as a potent instrument to foster provider trust and patient loyalty. Embracing a multichannel commercialization approach that integrates hospital, retail, and home care pathways will optimize market penetration and address the diverse preferences of end users.

This research employed a dual-phase methodology, commencing with an extensive secondary analysis of regulatory filings, clinical trial registries, patent settlements, and company disclosures to map the competitive landscape and launch timelines. Regulatory databases including the FDA Purple Book and EMA registers were systematically reviewed to confirm biosimilar designations, interchangeability statuses, and approval dates. Industry publications, peer-reviewed journals, and trade news sources provided current data on pricing strategies, post-launch performance, and supply chain dynamics.

Primary validation was achieved through structured interviews with key opinion leaders, including pharmacoeconomists, formulary decision-makers, and manufacturing executives. Insights from specialized distributors and major PBM representatives were integrated to triangulate access considerations and distribution channel nuances. Data synthesis involved cross-referencing market intelligence with publicly available financial disclosures and expert commentary to ensure accuracy and mitigate bias. Rigor was maintained through iterative peer review by technical specialists and adherence to established guidelines for health market analysis.

The surge of Ustekinumab biosimilars entering the U.S. and international markets has unequivocally shifted immunology therapeutics toward a more competitive, cost-efficient paradigm. Patent expiries and strategic settlements have unlocked multiple interchangeable candidates, enabling payers to leverage biosimilar adoption as a mechanism for advancing healthcare affordability. This transition is reinforced by aggressive price discounting, evidence-driven interchangeability, and evolving policy frameworks that endorse substitution and shared savings models.

Looking ahead, manufacturers that harness real-world evidence, fortify domestic manufacturing footprints, and cultivate differentiated patient support services will be best positioned to capture market share and build sustainable growth. Regional insights highlight the necessity of dynamic market entry plans tailored to regulatory environments, reimbursement structures, and infrastructure capacities across the Americas, EMEA, and Asia-Pacific. Ultimately, the Ustekinumab biosimilars landscape exemplifies the transformative potential of biosimilar innovation to enhance patient access, optimize healthcare resource allocation, and stimulate continued investment in advanced biologic therapies.

For tailored insights on the Ustekinumab biosimilars market and strategic guidance, reach out directly to Ketan Rohom, Associate Director of Sales & Marketing at 360iResearch. His expertise can guide you through our comprehensive report, ensuring you unlock critical data and nuanced analysis to inform your next moves. Secure your deep-dive into market segmentation, competitive positioning, and regulatory landscapes by connecting with Ketan today and empower your organization with the data-driven intelligence it needs to stay ahead.