Biosimilar Immunotherapeutics Development in 2025: Unleashing the Next Wave of Affordable Biologics and Transforming Global Immunotherapy Access. Explore the Market Forces, Technology Breakthroughs, and Strategic Moves Shaping the Industry’s Future.

• Executive Summary: 2025 Market Outlook and Key Takeaways
• Global Market Size, Growth Rate, and Forecasts to 2030
• Regulatory Landscape: Approvals, Harmonization, and Policy Trends
• Competitive Analysis: Leading Players and Emerging Innovators
• Pipeline Review: Key Biosimilar Immunotherapeutics in Development
• Technological Advances: Manufacturing, Analytics, and Formulation
• Market Drivers: Cost Savings, Access Expansion, and Payer Strategies
• Challenges: Patent Expiries, Interchangeability, and Physician Adoption
• Regional Insights: North America, Europe, Asia-Pacific, and Emerging Markets
• Future Outlook: Strategic Opportunities and Industry Growth Projections
• Sources & References

Executive Summary: 2025 Market Outlook and Key Takeaways

The biosimilar immunotherapeutics sector is poised for significant expansion in 2025, driven by a confluence of regulatory advancements, patent expirations, and increasing demand for cost-effective biologic therapies. As of 2025, the global market is witnessing a surge in biosimilar approvals and launches, particularly in the immunology and oncology segments, where monoclonal antibodies (mAbs) such as adalimumab, infliximab, and rituximab are central to treatment protocols.

Key industry leaders, including Amgen Inc., Sandoz (a division of Novartis), Celltrion, and Pfizer Inc., are actively expanding their biosimilar portfolios. These companies have established robust manufacturing and distribution networks, enabling them to capitalize on the growing acceptance of biosimilars among healthcare providers and payers. For example, Sandoz has been at the forefront of biosimilar development, with a strong pipeline targeting key immunotherapeutic biologics, while Celltrion continues to expand its global reach with biosimilars for autoimmune and oncological indications.

Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have streamlined approval pathways, resulting in accelerated market entry for biosimilar immunotherapeutics. The FDA’s Biosimilar Action Plan and the EMA’s tailored scientific advice for biosimilar developers are expected to further reduce development timelines and costs in 2025 and beyond. This regulatory momentum is anticipated to encourage new entrants and foster greater competition, ultimately driving down prices and improving patient access.

The expiration of patents for blockbuster biologics continues to be a major catalyst. In 2025, several high-value immunotherapeutic agents are losing exclusivity, opening the door for biosimilar competition. This trend is particularly pronounced in the U.S. and European markets, where healthcare systems are under pressure to contain costs without compromising clinical outcomes.

Looking ahead, the biosimilar immunotherapeutics market is expected to experience robust growth over the next few years. Industry analysts project increased investment in advanced manufacturing technologies, such as continuous bioprocessing and digital quality control, to enhance efficiency and scalability. Strategic collaborations between biosimilar developers and contract manufacturing organizations are also likely to intensify, as companies seek to accelerate product development and global market penetration.

In summary, 2025 marks a pivotal year for biosimilar immunotherapeutics, characterized by heightened regulatory support, expanding product pipelines, and intensifying competition among established and emerging players. The sector’s outlook remains positive, with significant opportunities for innovation, cost savings, and improved patient access to life-changing therapies.

Global Market Size, Growth Rate, and Forecasts to 2030

The global market for biosimilar immunotherapeutics is poised for robust expansion through 2030, driven by patent expirations of major biologics, increasing healthcare cost pressures, and expanding regulatory acceptance. As of 2025, the biosimilar immunotherapeutics segment—encompassing monoclonal antibodies (mAbs), fusion proteins, and other immune-modulating biologics—represents one of the fastest-growing areas within the broader biosimilars market.

Key players such as Amgen Inc., Sandoz (a division of Novartis), Celltrion Healthcare, Pfizer Inc., and Viatris Inc. are actively expanding their biosimilar immunotherapeutic portfolios. These companies have launched biosimilars for blockbuster immunotherapeutics such as adalimumab, infliximab, rituximab, and trastuzumab, with several more in late-stage development or awaiting regulatory approval. For example, Celltrion Healthcare has established a strong presence in biosimilar mAbs, particularly in Europe and Asia, and is expanding into the US market.

In 2025, the global biosimilar immunotherapeutics market is estimated to exceed $20 billion in annual sales, with a compound annual growth rate (CAGR) projected between 18% and 22% through 2030. This growth is underpinned by increasing adoption in both developed and emerging markets, as healthcare systems seek cost-effective alternatives to originator biologics. The US market, following the launch of multiple adalimumab biosimilars in 2023 and 2024, is expected to see accelerated uptake, while Europe continues to lead in biosimilar penetration due to earlier regulatory pathways and established physician confidence.

Looking ahead, the next few years will see a wave of biosimilar launches targeting additional immunotherapeutic biologics, including newer checkpoint inhibitors and interleukin inhibitors. Companies such as Amgen Inc. and Sandoz are investing in advanced manufacturing and analytical technologies to streamline development and ensure regulatory compliance. Furthermore, regulatory agencies in major markets are refining approval pathways to facilitate faster access and interchangeability, which is expected to further boost market growth.

By 2030, biosimilar immunotherapeutics are anticipated to account for a significant share of the global immunotherapy market, with ongoing innovation in formulation, delivery, and patient support programs enhancing their value proposition. The competitive landscape will likely intensify, benefiting healthcare systems and patients through increased access and reduced costs.

Regulatory Landscape: Approvals, Harmonization, and Policy Trends

The regulatory landscape for biosimilar immunotherapeutics is evolving rapidly in 2025, driven by increasing demand for affordable biologics and the maturation of global regulatory frameworks. Key agencies such as the U.S. Food and Drug Administration (U.S. Food and Drug Administration), European Medicines Agency (European Medicines Agency), and Pharmaceuticals and Medical Devices Agency (Pharmaceuticals and Medical Devices Agency) in Japan continue to refine their biosimilar approval pathways, emphasizing rigorous comparability exercises and post-marketing surveillance.

In 2025, the U.S. maintains its position as a leading market for biosimilar immunotherapeutics, with the FDA’s “Biosimilar Action Plan” fostering a more predictable and efficient review process. The FDA has approved multiple biosimilar monoclonal antibodies targeting key immunological diseases, including adalimumab, infliximab, and rituximab, with manufacturers such as Amgen Inc., Pfizer Inc., and Sandoz (a division of Novartis) leading the way. The agency’s focus on interchangeability designations is expected to further accelerate biosimilar uptake in the coming years.

The European Union remains at the forefront of biosimilar policy harmonization, with the EMA’s well-established guidelines serving as a model for other regions. The EMA has approved over 90 biosimilars, including several immunotherapeutics, and continues to update its guidance to reflect advances in analytical characterization and clinical study design. The agency’s collaboration with the World Health Organization (World Health Organization) and other international bodies is fostering greater global alignment, particularly in emerging markets.

Asia-Pacific regulators are also advancing harmonization efforts. Japan’s PMDA and South Korea’s Ministry of Food and Drug Safety (Ministry of Food and Drug Safety) have streamlined biosimilar approval processes, supporting domestic manufacturers such as Celltrion and Samsung Bioepis in expanding their global reach. China’s National Medical Products Administration (National Medical Products Administration) is accelerating biosimilar approvals, with a focus on immunotherapeutics for oncology and autoimmune diseases.

Looking ahead, regulatory convergence is expected to intensify, with agencies increasingly recognizing foreign approvals and harmonizing technical requirements. Initiatives such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are playing a pivotal role in standardizing biosimilar development and review. As a result, the next few years are likely to see faster global access to biosimilar immunotherapeutics, greater competition, and continued policy innovation to ensure safety, efficacy, and affordability.

Competitive Analysis: Leading Players and Emerging Innovators

The biosimilar immunotherapeutics sector is experiencing significant competitive activity as major pharmaceutical companies and emerging biotech firms vie for market share in a rapidly expanding global landscape. As of 2025, the field is characterized by both established leaders with extensive biologics portfolios and a new wave of innovators leveraging advanced manufacturing and analytical technologies.

Among the leading players, Pfizer Inc. continues to assert its dominance, having launched multiple biosimilar immunotherapeutics targeting key indications such as rheumatoid arthritis and oncology. Pfizer’s pipeline includes biosimilars referencing blockbuster monoclonal antibodies, and the company is investing in global manufacturing capacity to support anticipated demand. Similarly, Amgen Inc. remains a frontrunner, with a robust suite of approved biosimilars and ongoing development programs focused on immunology and oncology. Amgen’s strategic collaborations and in-house expertise in protein engineering have enabled it to maintain a competitive edge.

European-based Sandoz, a division of Novartis, is another key competitor, recognized for its early entry into the biosimilars market and a broad portfolio that includes immunotherapeutics for autoimmune diseases. Sandoz is actively expanding its reach in both established and emerging markets, leveraging its experience in regulatory navigation and commercialization. Celltrion Healthcare, headquartered in South Korea, has also emerged as a global force, particularly in the development and commercialization of biosimilar monoclonal antibodies. Celltrion’s focus on high-volume biologics and its vertically integrated manufacturing model have contributed to its rapid growth and international partnerships.

Emerging innovators are increasingly shaping the competitive landscape. Companies such as Biocon Limited (India) are gaining traction through strategic alliances and cost-effective production platforms, targeting both developed and developing markets. Biocon’s joint ventures and regulatory successes in the US and EU highlight the growing influence of non-Western manufacturers. Additionally, Samsung Biologics is leveraging its advanced bioprocessing capabilities and large-scale facilities to support both in-house and contract biosimilar development, positioning itself as a key partner for global pharmaceutical firms.

Looking ahead, the competitive dynamics are expected to intensify as more biosimilar immunotherapeutics receive regulatory approval and as patent expirations for major biologics accelerate. The entry of new players, particularly from Asia, and the adoption of next-generation manufacturing technologies are likely to drive further price competition and expanded patient access. Strategic collaborations, investment in analytical comparability, and regulatory harmonization will be critical factors shaping the market through 2025 and beyond.

Pipeline Review: Key Biosimilar Immunotherapeutics in Development

The biosimilar immunotherapeutics pipeline is experiencing significant momentum as of 2025, driven by patent expirations of major biologics and increasing global demand for cost-effective therapies. Key players are advancing candidates targeting blockbuster monoclonal antibodies (mAbs) and fusion proteins used in oncology, autoimmune, and inflammatory diseases.

Among the most active developers, Amgen Inc. continues to expand its biosimilar portfolio, building on its established presence with products referencing adalimumab, trastuzumab, and bevacizumab. Amgen’s pipeline includes biosimilars to immunotherapeutics such as pembrolizumab and nivolumab, with several candidates in late-stage clinical trials. Similarly, Sandoz, a division of Novartis, is advancing biosimilars for rituximab and eculizumab, and has announced plans to launch additional immunotherapy biosimilars by 2026.

Asian manufacturers are also prominent in the pipeline landscape. Celltrion is developing biosimilars for atezolizumab and ustekinumab, with phase III trials underway in multiple regions. Samsung Bioepis is progressing with biosimilars referencing pembrolizumab and denosumab, aiming for regulatory submissions in the US and EU within the next two years. These companies leverage advanced manufacturing and analytical capabilities to accelerate development timelines and meet stringent regulatory requirements.

In the United States, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both reported a surge in biosimilar applications for immunotherapeutics since 2023, reflecting the maturation of the sector. The FDA’s Biosimilar Action Plan and the EMA’s streamlined review pathways are expected to further facilitate approvals through 2025 and beyond.

Looking ahead, the biosimilar immunotherapeutics pipeline is expected to diversify, with candidates targeting newer checkpoint inhibitors and cytokine modulators. Companies such as Biocon and Merck KGaA are investing in next-generation biosimilars, including those for PD-1/PD-L1 inhibitors and interleukin antagonists. The competitive landscape is likely to intensify as more manufacturers enter the market, driving innovation in formulation, delivery, and patient support programs.

Overall, the period from 2025 onward is poised to see a wave of biosimilar immunotherapeutic launches, expanding patient access and reshaping the global biologics market.

Technological Advances: Manufacturing, Analytics, and Formulation

The development of biosimilar immunotherapeutics in 2025 is characterized by significant technological advances in manufacturing, analytics, and formulation, driven by the need for high-quality, cost-effective alternatives to originator biologics. The industry is witnessing a shift toward more efficient and scalable production platforms, with leading biopharmaceutical manufacturers investing in next-generation cell lines, single-use bioreactors, and continuous manufacturing processes. These innovations are designed to enhance product consistency, reduce contamination risks, and lower production costs, thereby accelerating time-to-market for biosimilars.

Key players such as Samsung Biologics, a global contract development and manufacturing organization (CDMO), are expanding their manufacturing capacities and integrating digitalization and automation into their facilities. In 2024, Samsung Biologics announced the completion of its fourth plant, which is now the world’s largest single biomanufacturing facility, and is actively supporting biosimilar production for multiple clients. Similarly, Biocon and its subsidiary Biocon Biologics have invested in advanced upstream and downstream processing technologies, including high-throughput screening and process analytical technologies (PAT), to ensure biosimilar immunotherapeutics meet stringent regulatory requirements for similarity and quality.

Analytical characterization remains a cornerstone of biosimilar development. The adoption of state-of-the-art mass spectrometry, capillary electrophoresis, and next-generation sequencing enables detailed profiling of biosimilar candidates, ensuring structural and functional equivalence to reference products. Companies like Sandoz, a division of Novartis and a pioneer in biosimilars, have publicly emphasized their use of advanced analytics to support regulatory submissions and post-approval monitoring. These analytical advances are complemented by the integration of artificial intelligence and machine learning tools to interpret complex datasets, optimize process parameters, and predict product behavior.

Formulation technologies are also evolving, with a focus on improving the stability, delivery, and patient convenience of biosimilar immunotherapeutics. Innovations include the development of high-concentration, low-viscosity formulations suitable for subcutaneous administration, as well as the use of novel excipients to enhance shelf-life and reduce immunogenicity. Amgen, a leader in both originator and biosimilar biologics, has reported progress in formulation science, enabling the launch of biosimilars with improved administration profiles.

Looking ahead, the convergence of these technological advances is expected to further streamline biosimilar immunotherapeutics development, reduce costs, and expand patient access globally. As regulatory agencies continue to harmonize guidelines and encourage innovation, the sector is poised for robust growth and increased competition through 2025 and beyond.

Market Drivers: Cost Savings, Access Expansion, and Payer Strategies

The biosimilar immunotherapeutics market in 2025 is being shaped by a confluence of economic and healthcare system drivers, with cost savings, expanded patient access, and evolving payer strategies at the forefront. As biologic immunotherapies for conditions such as rheumatoid arthritis, psoriasis, and various cancers continue to represent significant portions of pharmaceutical expenditures, biosimilars offer a compelling solution to rising healthcare costs. The introduction of biosimilar monoclonal antibodies and fusion proteins—such as adalimumab, infliximab, and rituximab—has already demonstrated substantial price reductions in markets where competition is robust.

Major manufacturers, including Pfizer, Amgen, Sandoz, and Celltrion, have expanded their biosimilar immunotherapeutic portfolios, driving down costs through increased supply and competition. For example, the entry of multiple adalimumab biosimilars in the US and European markets in 2023–2024 has led to price discounts of 20–50% compared to reference products, with further reductions anticipated as more products gain approval and market share in 2025. These savings are not only realized by payers but are also being passed on to patients through lower co-pays and improved insurance coverage.

Access expansion is another critical driver. Biosimilars are enabling broader patient populations to receive advanced immunotherapies that were previously limited by high costs. National health systems and private insurers are increasingly adopting biosimilar-friendly policies, such as automatic substitution and preferential formulary placement, to encourage uptake. In the European Union, countries like Germany and the UK have reported biosimilar penetration rates exceeding 70% for certain immunotherapeutics, a trend expected to continue as more biosimilars enter the market and as prescriber confidence grows.

Payer strategies are rapidly evolving to maximize the benefits of biosimilars. Insurers and pharmacy benefit managers are leveraging competitive tendering, exclusive contracting, and step therapy protocols to promote biosimilar use. These strategies are supported by ongoing real-world evidence demonstrating the safety and efficacy equivalence of biosimilars to their reference products. Leading payers in the US and Europe are expected to further refine these approaches in 2025, with a focus on outcome-based agreements and value-based pricing models.

Looking ahead, the continued development and approval of biosimilar immunotherapeutics are poised to accelerate cost savings and access gains globally. As regulatory pathways mature and manufacturing capabilities expand, the market is likely to see increased competition, further price erosion, and broader adoption—solidifying biosimilars as a cornerstone of sustainable immunotherapy delivery.

Challenges: Patent Expiries, Interchangeability, and Physician Adoption

The development of biosimilar immunotherapeutics in 2025 is shaped by a complex interplay of patent expiries, regulatory hurdles around interchangeability, and the ongoing challenge of physician adoption. As the patents for several blockbuster biologic immunotherapies—such as monoclonal antibodies targeting inflammatory and oncological diseases—expire, the opportunity for biosimilar entry expands. In 2025, key molecules like adalimumab, trastuzumab, and rituximab continue to see biosimilar competition in major markets, with companies such as Amgen, Sandoz, Celltrion, and Viatris leading the charge. These firms have established manufacturing capabilities and global distribution networks, positioning them to capitalize on the expanding biosimilar landscape.

However, the expiration of patents does not automatically translate to rapid biosimilar uptake. Regulatory requirements for demonstrating biosimilarity and, crucially, interchangeability remain stringent. In the United States, the Food and Drug Administration (FDA) has approved a limited number of biosimilars as interchangeable, a designation that allows pharmacists to substitute a biosimilar for its reference product without prescriber intervention. As of 2025, only a handful of immunotherapeutic biosimilars have achieved this status, reflecting the rigorous data requirements for switching studies and post-marketing surveillance. Companies like Pfizer and AbbVie (the latter as both innovator and biosimilar developer) are actively engaged in generating the necessary evidence to support interchangeability claims.

Physician adoption remains a critical bottleneck. Despite growing clinical evidence supporting the safety and efficacy of biosimilar immunotherapeutics, prescribers often express concerns about immunogenicity, subtle differences in manufacturing, and the robustness of switching data. Educational initiatives by industry leaders and professional societies are ongoing, but uptake varies significantly by region and therapeutic area. For example, Sandoz and Celltrion have invested in physician outreach and real-world evidence generation to build confidence in biosimilar use, particularly in rheumatology and oncology.

Looking ahead, the outlook for biosimilar immunotherapeutics is cautiously optimistic. As more patents expire and regulatory pathways for interchangeability mature, the next few years are expected to see increased biosimilar approvals and broader adoption. However, overcoming entrenched prescribing habits and ensuring robust post-marketing surveillance will remain essential for realizing the full potential of biosimilar immunotherapeutics in global healthcare.

Regional Insights: North America, Europe, Asia-Pacific, and Emerging Markets

The global landscape for biosimilar immunotherapeutics is rapidly evolving, with significant regional differences shaping development, regulatory pathways, and market adoption as of 2025 and looking ahead. North America, Europe, Asia-Pacific, and emerging markets each present unique opportunities and challenges for stakeholders in this sector.

North America remains a pivotal region, driven by the United States’ large biologics market and evolving regulatory frameworks. The U.S. Food and Drug Administration (FDA) continues to refine its biosimilar approval process, with a growing number of biosimilar immunotherapeutics—such as adalimumab, infliximab, and rituximab—gaining approval and market traction. Major players like Pfizer Inc., Amgen Inc., and Viatris Inc. are actively expanding their biosimilar portfolios, leveraging both in-house R&D and strategic partnerships. The U.S. market is expected to see increased competition and price erosion in the next few years, particularly as interchangeability designations become more common and payer acceptance grows.

Europe continues to lead in biosimilar adoption, supported by a mature regulatory environment under the European Medicines Agency (EMA). The region has witnessed robust uptake of biosimilar immunotherapeutics, with countries like Germany, the UK, and the Nordics achieving high penetration rates. Companies such as Sandoz (a division of Novartis), Celltrion Healthcare, and Biogen Inc. are prominent, with Sandoz in particular maintaining a leadership position in biosimilar launches and pipeline development. The European market is expected to remain dynamic, with new biosimilar entrants and ongoing policy initiatives to further encourage switching and physician confidence.

Asia-Pacific is emerging as a powerhouse in biosimilar immunotherapeutics development and manufacturing. Countries like South Korea, India, and China are investing heavily in biosimilar R&D and regulatory harmonization. Celltrion Healthcare and Samsung Bioepis (a joint venture between Samsung Biologics and Biogen) are at the forefront, with a strong pipeline and global ambitions. Indian firms such as Biocon Limited are also expanding their global footprint, particularly in monoclonal antibody biosimilars. The region is expected to see accelerated approvals and increased exports, especially as local regulatory agencies align more closely with international standards.

Emerging markets in Latin America, the Middle East, and Africa are gradually increasing their participation in biosimilar immunotherapeutics, driven by the need for affordable biologics. Local manufacturers are beginning to collaborate with global leaders to build capacity and navigate regulatory complexities. While challenges remain—such as infrastructure, regulatory harmonization, and market access—these regions are poised for growth as biosimilar awareness and acceptance rise.

Overall, the next few years will see intensified competition, broader patient access, and continued innovation in biosimilar immunotherapeutics across all regions, with global leaders and regional champions shaping the future landscape.

Future Outlook: Strategic Opportunities and Industry Growth Projections

The biosimilar immunotherapeutics sector is poised for significant expansion in 2025 and the following years, driven by patent expirations of major biologics, increasing healthcare cost pressures, and evolving regulatory frameworks. As of 2025, several blockbuster immunotherapeutic biologics—such as adalimumab, trastuzumab, and rituximab—have already seen biosimilar competition in key markets, with more biosimilars expected to launch as additional patents expire. This trend is particularly pronounced in the United States and Europe, where regulatory agencies have streamlined approval pathways and fostered greater market access.

Major pharmaceutical companies and specialized biosimilar developers are intensifying their investments in immunotherapeutic biosimilars. Pfizer Inc. and Amgen Inc. have established robust biosimilar portfolios, including monoclonal antibodies targeting autoimmune diseases and cancers. Sandoz, a division of Novartis, remains a global leader in biosimilars, with a strong focus on immunology and oncology products. Celltrion and Samsung Bioepis, both based in South Korea, have also emerged as key players, leveraging advanced manufacturing capabilities and global partnerships to expand their reach in North America, Europe, and emerging markets.

The competitive landscape is further shaped by strategic collaborations and licensing agreements. For example, Viatris (formerly Mylan) has partnered with Biocon to co-develop and commercialize biosimilar monoclonal antibodies, accelerating global access to affordable immunotherapeutics. These alliances are expected to proliferate as companies seek to share development risks, navigate complex regulatory requirements, and optimize commercialization strategies.

Regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency continue to refine biosimilar guidelines, with a focus on interchangeability, extrapolation of indications, and post-marketing surveillance. These efforts are anticipated to enhance physician and patient confidence in biosimilar immunotherapeutics, further driving adoption. Additionally, the expansion of biosimilar manufacturing capacity—particularly in Asia and Eastern Europe—will support global supply chain resilience and cost efficiencies.

Looking ahead, the biosimilar immunotherapeutics market is expected to experience double-digit annual growth rates through the late 2020s. Strategic opportunities will center on next-generation biosimilars, improved delivery systems, and digital health integration to support patient adherence. As more countries implement supportive policies and reimbursement frameworks, biosimilar immunotherapeutics are set to play a pivotal role in expanding access to life-saving treatments and reducing the economic burden of chronic immune-mediated diseases.

Sources & References

• Sandoz
• Celltrion
• Viatris Inc.
• European Medicines Agency
• Pharmaceuticals and Medical Devices Agency
• World Health Organization
• Ministry of Food and Drug Safety
• Samsung Bioepis
• ICH
• Biocon Limited
• Samsung Biologics
• Biogen Inc.