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Biosimilars 2026
About Conference
We are pleased to welcome you to the 7th Annual Congress on Biosimilars and Future Biotherapeutics, taking place on April 27–28, 2026 in the captivating city of Paris, France. This premier global event brings together leading scientists, researchers, regulatory authorities, biopharmaceutical experts, and healthcare professionals to explore the current landscape and future direction of biosimilars and biotherapeutic innovations.
With the theme "Advancing Access and Innovation in Biologics" the congress aims to foster meaningful discussions on the latest advancements, regulatory challenges, market dynamics, and scientific breakthroughs shaping the biosimilars industry. Sessions will cover a wide range of topics, including biosimilar development and approval pathways, analytical and clinical comparability, immunogenicity, biobetters, real-world evidence, and the impact of biosimilars on healthcare economics and patient access.
The congress will feature keynote addresses, scientific sessions, panel discussions, industry presentations, and interactive networking opportunities, offering participants a unique platform to share knowledge, forge collaborations, and drive innovation forward in this rapidly evolving sector.
Join us in Paris to be part of an inspiring exchange of ideas and strategies that will define the future of biologics, biosimilar adoption, and global biotherapeutic access.. Its role in the Enlightenment, the French Revolution, and the world wars has left an indelible mark on global history.The city is adorned with historical landmarks that reflect its rich past and architectural grandeur. Iconic sites such as the Eiffel Tower, Notre-Dame Cathedral, Arc de Triomphe, Sainte-Chapelle, and the Palace of Versailles (just outside the city) serve as vivid reminders of the city’s royal, revolutionary, and artistic heritage. Each arrondissement (district) tells its own story, from the bohemian charm of Montmartre to the regal elegance of the Champs-Élysées and the intellectual vibrance of the Latin Quarter.Culturally, Paris is unmatched.
The 7th edition of this flagship event will feature a robust scientific program that integrates academic excellence with clinical relevance and real-world applications. Key highlights of the conference include:
- Renowned Keynote Speakers – Hear from influential voices and visionaries in women’s health who are leading groundbreaking work in research, clinical care, and global health policy.
- Cutting-edge Research Presentations – Stay updated with the latest scientific developments through plenary sessions, oral abstracts, and poster presentations.
- Interactive Workshops & Panel Discussions – Participate in hands-on learning experiences, case-based sessions, and interdisciplinary panels that encourage active collaboration and skill-building.
- Networking Opportunities – Connect with peers, mentors, collaborators, and thought leaders from diverse backgrounds through structured networking events and social engagements.
- Industry & Innovation Showcase – Explore new tools, technologies, and services presented by global organizations, startups, and healthcare innovators.
Sessions and Tracks
Advancements in Biosimilar Development Technologies the latest scientific and technical innovations that are revolutionizing the way biosimilars are developed, manufactured, and brought to market. As the global demand for affordable biologic therapies grows, the need for efficient and precise biosimilar development strategies has become more critical than ever. the growing role of analytical characterization tools, such as high-resolution mass spectrometry, capillary electrophoresis, and advanced chromatography techniques, in demonstrating structural and functional similarity to reference biologics. These technologies are critical for establishing biosimilarity at the molecular level, which is the cornerstone of regulatory approval. In addition, attendees will learn how process analytical technology (PAT) and quality by design (QbD) principles are being integrated into biosimilar development pipelines to ensure greater process control and regulatory compliance. The session will also highlight advancements in in-silico modeling, bioinformatics, and machine learning applications that are streamlining development timelines and optimizing manufacturing workflows. Whether you are a researcher, manufacturer, or regulatory professional, this session will provide valuable knowledge on the future landscape of biosimilar development and the tools driving it forward.
Regulatory Pathways and Global Harmonization evolving regulatory frameworks that govern the approval and oversight of biosimilars across different regions, and the growing need for global alignment to support broader patient access and industry innovation. Biosimilar development is uniquely complex due to the intricate nature of biologic medicines, and regulatory agencies have developed specialized pathways to ensure these products meet rigorous standards for quality, safety, efficacy, and biosimilarity to their reference products. Key topics will include comparative overviews of regulatory pathways established by major agencies such as the U.S. FDA, European Medicines Agency (EMA), World Health Organization (WHO), Japan’s PMDA, and regulatory bodies in emerging markets. As the global biosimilar market expands, the call for harmonization and convergence of regulatory standards is becoming stronger. reduce duplication in clinical trials, and facilitate mutual recognition agreements, which can ultimately lead to faster approvals and reduced development costs. Real-world case studies will be presented to illustrate how global companies are navigating multiple regulatory environments and adapting to shifting expectations.
Clinical Trials & Comparability Studies for Biosimilars a comprehensive overview of the scientific and regulatory methodologies involved in demonstrating biosimilarity through robust clinical and analytical data. Unlike generic drugs, biosimilars are not exact copies of their reference biologics due to the complexity of large, protein-based molecules. Therefore, establishing biosimilarity requires a multi-tiered approach involving a combination of analytical characterization, non-clinical studies, and clinical trials—particularly focused on pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, efficacy, and safety. focusing on how these trials are structured to confirm that there are no clinically meaningful differences between a biosimilar and its reference product. PK/PD studies, which are increasingly recognized as powerful tools to reduce the need for large-scale efficacy trials, particularly when strong analytical and functional similarity has already been demonstrated. assess anti-drug antibody (ADA) responses and their impact on efficacy and safety, along with strategies to mitigate immunogenic risks during clinical development. The use of real-world evidence (RWE) and post-marketing data to supplement clinical trial findings will also be discussed, especially in regions where regulatory bodies are accepting RWE to support extrapolation of indications or approval in new markets.
The transformative role of biosimilars in expanding access to life-saving biologic therapies for patients with cancer and chronic immune-mediated disorders. Oncology and autoimmune diseases represent two of the largest and most impactful therapeutic areas where biologics have revolutionized treatment paradigms. However, the high cost of reference biologic drugs has historically posed significant barriers to patient access, especially in resource-constrained healthcare systems. Biosimilars, with their comparable efficacy and safety at reduced costs, have emerged as a game-changing solution to improve treatment affordability and accessibility without compromising therapeutic outcomes. biosimilar use in conditions such as breast cancer, colorectal cancer, non-Hodgkin lymphoma, rheumatoid arthritis, psoriasis, ankylosing spondylitis, and inflammatory bowel disease. Special emphasis will be placed on biosimilars of monoclonal antibodies and targeted therapies such as trastuzumab, rituximab, bevacizumab, infliximab, adalimumab, and etanercept, which have already gained approval and widespread use across various regions. Attendees will gain insights into the design and outcomes of pivotal clinical trials supporting the approval of these biosimilars, as well as real-world evidence that demonstrates their effectiveness in clinical practice. Panelists will discuss the perspectives of oncologists, rheumatologists, pharmacists, and patients regarding the use of biosimilars in sensitive disease areas, where trust and familiarity with reference products remain high.
Biobetters: The Next Generation of Biologics will delve into the emerging class of biologic drugs known as biobetters, which are engineered to surpass their reference biologics in terms of efficacy, safety, pharmacokinetics, or convenience. While biosimilars are developed to closely mimic the original biologics without clinically meaningful differences, biobetters go a step further by enhancing therapeutic performance through strategic modifications. As the biologics market continues to evolve, biobetters represent a rapidly growing opportunity for innovation in biologic therapy—offering significant clinical and commercial potential. These advanced modifications can result in reduced dosing frequency, improved patient adherence, and potentially superior therapeutic outcomes compared to first-generation biologics. Biobetters are increasingly being positioned as a viable next step in therapeutic evolution, not only to improve clinical benefits but also to extend product lifecycles and differentiate in a competitive market.Real-world examples of successful biobetters—such as dulaglutide (a biobetter of GLP-1 receptor agonists) and darbepoetin alfa (a modified erythropoiesis-stimulating agent)will be discussed to illustrate their clinical and market advantages. Attendees will gain insights into the regulatory landscape surrounding biobetters, which typically follow the new biologic license application (BLA) or marketing authorization pathways rather than the abbreviated biosimilar approval process, due to their enhanced properties.
Immunogenicity Assessment and Risk Management” will explore one of the most critical aspects of biosimilar and biotherapeutic development—evaluating and managing immune responses to biologic products. Immunogenicity refers to the ability of a therapeutic protein to provoke an immune response in the body, which can potentially alter the drug’s efficacy, cause adverse events, or lead to treatment failure. Given the complex structure and manufacturing processes of biologics, even minor variations in formulation, storage, or handling can influence immunogenic potential. Therefore, accurate assessment and effective risk mitigation are essential components of the regulatory and clinical development pathway for biosimilars and next-generation biotherapeutics. bioanalytical strategy design, assay validation, and standardization methods used to compare immunogenic profiles between biosimilars and their reference products. Special emphasis will be placed on interpreting immunogenicity data in both preclinical and clinical settings, and understanding its impact on pharmacokinetics, safety, and therapeutic effectiveness. Regulatory guidance provided by agencies such as the FDA, EMA, and WHO on immunogenicity evaluation during product development and post-marketing surveillance. Experts will discuss risk management strategies,
Pharmacovigilance and Post-Marketing Surveillance” will delve into the critical role of long-term safety monitoring in the lifecycle management of biosimilars and other biotherapeutic products. While pre-approval clinical trials provide essential data on the safety, efficacy, and quality of biosimilars, they are often conducted on limited populations over defined periods. Therefore, once a biosimilar enters the market and is exposed to broader, more diverse patient populations under real-world conditions, robust pharmacovigilance systems become essential to continuously monitor and assess product performance, detect rare or unexpected adverse effects, and maintain patient safety.Biologics, including biosimilars, have unique characteristics—such as structural complexity and sensitivity to manufacturing processes—that make them more prone to variability than traditional small-molecule drugs. This variability can influence immunogenicity, therapeutic response, and long-term safety. In this context, the importance of post-marketing surveillance (PMS). Key components of pharmacovigilance—such as Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), signal detection, benefit-risk assessment, and product traceability. European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Health Canada, and World Health Organization (WHO) enforce post-approval monitoring through structured reporting mechanisms and mandatory safety programs.
Biosimilars, which are highly similar to already approved originator biologics with no clinically meaningful differences in terms of safety, purity, and potency, have emerged as a critical tool in reducing the financial burden on healthcare systems worldwide. The high cost of biologics has been a persistent challenge, often limiting access to life-saving treatments for patients with chronic and complex conditions such as cancer, autoimmune diseases, and rare genetic disorders. Biosimilars address this gap by increasing competition in the biologics market, leading to price reductions and expanded patient access.One of the major economic advantages of biosimilars is their ability to lower direct drug costs. Although the development and manufacturing of biosimilars involve significant investment, these costs are still considerably lower than those required for developing novel biologics, primarily because biosimilars bypass much of the early-stage discovery and preclinical work. This economic efficiency is reflected in their market pricing, with biosimilars typically being 15–30% less expensive than their reference products. In large-scale healthcare systems, such cost savings translate into substantial financial relief, enabling the reallocation of resources to other areas of patient care, research, and public health initiatives. Additionally, competition from biosimilars encourages originator manufacturers to reduce prices or offer patient support programs, further driving down overall treatment costs.From a broader health economics perspective, biosimilars also contribute to improved cost-effectiveness ratios in therapeutic interventions.
The biosimilar landscape continues to evolve dynamically across the globe, driven by increasing demand for cost-effective biologic therapies, improved regulatory clarity, and rising acceptance among payers, patients, and providers. Biosimilar market access and reimbursement policies play a crucial role in shaping adoption trends worldwide. While Europe leads in biosimilar penetration owing to supportive health policies and tender-based pricing models, the U.S. has shown steady growth post-implementation of the Biologics Price Competition and Innovation Act (BPCIA). In Asia and Latin America, regulatory harmonization and national incentive schemes are paving the way for broader biosimilar uptake. Interchangeability and substitution policies vary significantly by region, influencing market dynamics and physician behavior. The FDA’s criteria for interchangeability demand rigorous switching studies, whereas the EU emphasizes physician discretion and patient consent without requiring formal designation. These differing scientific and regulatory frameworks underscore the importance of robust real-world evidence and pharmacovigilance to support confident switching between reference products and biosimilars. Critical to ensuring biosimilar quality and efficacy are stringent manufacturing and quality control measures, including Chemistry, Manufacturing, and Controls (CMC) documentation, process validation, and compliance with current Good Manufacturing Practices (GMP).
The successful integration of biosimilars into mainstream healthcare largely depends on clear, supportive market access and reimbursement policies that encourage uptake while ensuring affordability and sustainability. Biosimilars, though scientifically equivalent to their reference biologics, face a distinct set of challenges in entering global markets. These include navigating complex regulatory landscapes, patent exclusivity timelines, and achieving acceptance from payers, providers, and patients. Reimbursement policies, often set by national or regional healthcare authorities, play a critical role in shaping how quickly and widely biosimilars are adopted. In the European Union, for example, well-established policies and centralized procurement systems have made it a global leader in biosimilar penetration. The European Medicines Agency (EMA) has approved numerous biosimilars over the past decade, and countries like Germany, the Netherlands, and the UK have implemented price-linked reimbursement schemes, prescribing quotas, and financial incentives for physicians, all of which have encouraged biosimilar use. Tendering systems, particularly in Scandinavian countries, have fostered competitive pricing and rapid market shifts, with biosimilars capturing significant market shares within months of entry. In contrast, the United States has been slower to adopt biosimilars, largely due to more complex market dynamics and a lack of automatic substitution laws. The U.S. Centers for Medicare & Medicaid Services (CMS) has taken steps to improve biosimilar reimbursement, such as assigning unique Healthcare Common Procedure Coding System (HCPCS) codes and providing add-on payments to incentivize use in hospital settings
Interchangeability and substitution policies play a pivotal role in the broader adoption and integration of biosimilars into clinical practice. These policies define the conditions under which a biosimilar can be substituted for its reference biologic without the intervention of the prescribing healthcare provider. While biosimilars are approved based on their similarity to reference products in terms of safety, efficacy, and quality, interchangeability is a higher regulatory standard in some regions—particularly the United States—requiring additional data to demonstrate that switching between the biosimilar and its reference product does not result in diminished safety or efficacy. In the U.S., the Food and Drug Administration (FDA) defines an interchangeable biosimilar as one that may be substituted at the pharmacy level, similar to how generic drugs are handled, provided the biosimilar meets rigorous criteria through switching studies. These studies are designed to evaluate whether alternating between the reference product and the biosimilar causes any adverse effects or compromises therapeutic outcomes. Although several biosimilars have gained FDA approval, only a few have been designated as interchangeable, highlighting the stringent nature of the process and the regulatory caution applied to biologic therapies. In contrast, the European Medicines Agency (EMA) does not grant an interchangeability designation per se; instead, it leaves the decision to individual EU member states.
The manufacturing and quality control of biosimilars are central to ensuring their safety, efficacy, and similarity to reference biologics. Unlike small-molecule drugs, which are chemically synthesized and easily replicated, biosimilars are large, complex proteins produced using living cells, making their manufacturing process highly sensitive and technically demanding. The cornerstone of biosimilar development lies in the robust characterization of the reference biologic, followed by the careful design of a cell line and production process that can replicate the reference product’s structure and function as closely as possible. This involves extensive analytical studies to evaluate critical quality attributes (CQAs) such as protein folding, glycosylation patterns, charge variants, and impurity profiles. These attributes must remain within an acceptable range to demonstrate biosimilarity, and any differences must be scientifically justified as non-impactful on clinical performance. The Chemistry, Manufacturing, and Controls (CMC) requirements for biosimilars are rigorous and form a significant portion of the regulatory submission. The process begins with cell line development, where a stable and high-yielding expression system is selected and genetically engineered to produce the target protein. Following this, upstream and downstream processing steps—including fermentation, purification, filtration, and formulation—are optimized to ensure product consistency, scalability, and stability.
The perspectives of patients and physicians play a pivotal role in the acceptance and integration of biosimilars into everyday clinical practice. Despite strong regulatory assurances of biosimilarity in terms of safety, efficacy, and quality, perceptions and confidence levels among healthcare providers and patients significantly influence prescribing behaviors, switching decisions, and overall market uptake. For physicians, biosimilars represent an opportunity to offer cost-effective treatment options, expand patient access, and optimize healthcare resources. However, concerns often linger regarding the clinical equivalence of biosimilars, especially in complex therapeutic areas such as oncology, rheumatology, and immunology. Many clinicians express caution about switching stable patients from originator biologics to biosimilars, largely due to a lack of long-term real-world data, fears about immunogenicity, or the perception that even minor structural differences might impact clinical outcomes. These concerns are particularly evident in regions where biosimilars are newly introduced, or where regulatory guidance on interchangeability and substitution is limited or inconsistent. Physicians’ willingness to prescribe biosimilars is heavily influenced by their level of education and experience with these products. Continuing medical education, access to comparative data, and positive clinical experiences can help shift attitudes from skepticism to acceptance. Endorsement by professional societies and inclusion of biosimilars in clinical guidelines also provide reassurance and promote wider adoption
The future of monoclonal antibodies (mAbs) and fusion proteins is poised for significant innovation, offering new possibilities in the treatment of cancer, autoimmune diseases, infectious diseases, and other complex conditions. As some of the most successful classes of biotherapeutics, mAbs and fusion proteins have transformed modern medicine, delivering high specificity, targeted mechanisms of action, and favorable safety profiles. However, their continued evolution is being driven by the need for enhanced efficacy, reduced immunogenicity, improved patient convenience, and affordability. The next generation of these biologics is characterized by advanced engineering strategies that go beyond traditional formats. For monoclonal antibodies, this includes the development of bispecific antibodies, which can bind two different antigens or epitopes simultaneously—enhancing their ability to bring immune cells directly to target cells or modulate multiple signaling pathways. These molecules are particularly promising in oncology and immune modulation, where they can offer synergistic therapeutic effects and overcome resistance mechanisms seen in standard monoclonal therapies. Fusion proteins, meanwhile, are being increasingly optimized to combine the functional domains of multiple proteins into a single molecule, often coupling the targeting capability of an antibody with the biological activity of a receptor, ligand, or enzyme. This design enables improved pharmacokinetics, prolonged half-life, and precise tissue targeting. For example, Fc-fusion proteins have shown great success in autoimmune diseases by combining the receptor-binding domain of a cytokine with the constant region of immunoglobulins to extend systemic circulation.·
The integration of artificial intelligence (AI) and digital tools in biotherapeutics is revolutionizing how biologic drugs, including biosimilars and innovative biologics, are researched, developed, manufactured, and administered. Traditionally, the development of biotherapeutics has been a lengthy, complex, and expensive process, involving high levels of uncertainty, especially in early discovery and clinical translation. AI technologies—ranging from machine learning and deep learning to natural language processing and predictive analytics—are now addressing these challenges by enabling faster, more accurate decision-making across the biotherapeutic value chain. In drug discovery, AI algorithms are used to screen vast libraries of compounds, predict protein–protein interactions, and identify potential therapeutic targets. By analyzing massive datasets from genomic, proteomic, and clinical sources, AI can uncover novel disease pathways and biomolecular relationships, significantly accelerating lead identification and optimization for monoclonal antibodies, fusion proteins, and other biotherapeutics. One of the most transformative applications of AI in biotherapeutics is in protein structure prediction and design. Tools like AlphaFold, developed by DeepMind, have demonstrated the ability to predict complex protein folding patterns with remarkable accuracy, aiding in the design of biologics with improved stability, specificity, and reduced immunogenicity.
The global adoption of biosimilars has accelerated over the past decade, offering promising solutions to reduce healthcare costs and expand access to life-saving biologic therapies. However, the pace and extent of biosimilar uptake vary widely across regions due to differences in regulatory frameworks, healthcare infrastructure, market dynamics, and stakeholder perceptions. In Europe, biosimilars have seen the most successful integration, thanks to the early establishment of clear regulatory pathways by the European Medicines Agency (EMA), supportive health policies, and well-structured procurement systems. Countries such as Germany, the Netherlands, and Norway have implemented effective tendering processes, physician incentives, and education programs, leading to rapid market penetration and significant cost savings. European case studies demonstrate that policy-driven strategies, coupled with real-world evidence and physician engagement, can overcome initial skepticism and encourage biosimilar utilization in complex disease areas such as oncology and rheumatology.In the United States, biosimilar adoption has been slower but is steadily progressing. ·
The formulation and delivery systems for biologics have evolved significantly over the past two decades, becoming a vital component in optimizing the efficacy, safety, stability, and patient experience of these complex therapies. Unlike small-molecule drugs, biologics such as monoclonal antibodies, fusion proteins, and therapeutic enzymes are large, fragile molecules produced using living cells. They are highly sensitive to environmental conditions and can degrade under stress, making their formulation and delivery particularly challenging. The primary goals in biologic formulation are to maintain structural integrity, prevent aggregation, ensure biological activity, and enable long-term stability. Achieving these goals requires the careful selection of excipients—such as buffers, surfactants, stabilizers, and preservatives—that support protein stability without introducing toxicity or immunogenicity. Advanced analytical tools are used during formulation development to monitor degradation pathways, including deamidation, oxidation, and aggregation, which can compromise therapeutic efficacy and safety. The formulation and delivery systems for biologics have evolved significantly over the past two decades, becoming a vital component in optimizing the efficacy, safety, stability, and patient experience of these complex therapies. Unlike small-molecule drugs, biologics such as monoclonal antibodies, fusion proteins, and therapeutic enzymes are large, fragile molecules produced using living cells. ·
The emergence of biosimilars in rare and orphan diseases marks a critical turning point in the accessibility and affordability of advanced biologic therapies for small and underserved patient populations. Rare diseases, defined in many regions as conditions affecting a small percentage of the population, often lack effective treatments due to limited commercial incentives and high development costs. When therapies do exist—typically in the form of biologics such as monoclonal antibodies, enzyme replacement therapies, or fusion proteins—they are frequently priced at a premium, placing a substantial burden on healthcare systems and making access difficult for patients, particularly in low- and middle-income countries. The introduction of biosimilars offers a potential solution to this challenge by increasing treatment options and lowering costs, thereby expanding access to life-altering or life-saving therapies for patients with rare conditions. Despite the enormous potential, the development and adoption of biosimilars in the context of rare diseases face unique scientific, regulatory, and market-related challenges. From a scientific perspective, rare diseases often involve highly complex biologics and a limited understanding of disease mechanisms, which makes demonstrating biosimilarity more difficult. Moreover, the scarcity of patients can complicate the design and execution of clinical trials. In many cases, traditional head-to-head efficacy trials are not feasible due to the small number of eligible participants. ·
The development of biosimilars is a complex, resource-intensive process that requires advanced scientific capabilities, regulatory expertise, and significant financial investment. To overcome these challenges and accelerate product development while managing costs and risks, stakeholders across the biopharmaceutical industry are increasingly turning to collaborative models. These partnerships—ranging from public-private alliances and academic-industry collaborations to joint ventures and contract development and manufacturing organization (CDMO) engagements—have become a cornerstone of modern biosimilar strategy. At the heart of these collaborative approaches is the recognition that no single entity can address the technical, regulatory, and market-access complexities of biosimilars alone, particularly in a global environment characterized by diverse regulatory requirements and competitive pressures. Public-private partnerships (PPPs) are one of the most impactful models in biosimilar development, especially in low- and middle-income countries where capacity building and affordable access are key priorities. Government agencies, non-profits, and international organizations such as the World Health Organization (WHO), the Bill & Melinda Gates Foundation, and the Coalition for Epidemic Preparedness Innovations (CEPI) often team up with local manufacturers or multinational pharmaceutical companies to facilitate technology transfer, scale-up manufacturing, and streamline regulatory approval for biosimilars.·
The future of biotherapeutics is rapidly advancing toward a new era defined by cell and gene therapies (CGTs)—transformative modalities that go beyond symptom management to offer the possibility of long-term remission, correction of genetic defects, and even cures. Unlike traditional biologics or biosimilars that generally target disease pathways with proteins such as monoclonal antibodies, cell and gene therapies work at a deeper level by repairing, replacing, or reprogramming the body's cellular and genetic machinery. These therapies hold immense promise, particularly in treating inherited genetic disorders, hematologic malignancies, solid tumors, and rare diseases for which no curative options previously existed. By harnessing living cells or directly modifying DNA, CGTs aim to address the root cause of disease, marking a paradigm shift in medical innovation and personalized medicine. Gene therapies involve delivering genetic material—either by inserting functional genes into a patient's cells or editing defective ones using tools like CRISPR-Cas9 or zinc finger nucleases. These technologies are being explored for conditions such as spinal muscular atrophy, hemophilia, Duchenne muscular dystrophy, and certain forms of inherited blindness. Vectors, particularly adeno-associated viruses (AAVs), are used to transport the genetic payload to target cells, though newer non-viral delivery methods are also emerging.
Market Analysis
The global biosimilars and biotherapeutics market is experiencing a period of aggressive growth—valued at approximately?$23.8?billion in 2023 and projected to expand to $69.2?billion by 2029 at a CAGR of ~19.4%? Alternative estimates indicate even broader trajectories, reaching nearly $175.99?billion by 2034 (CAGR ~17.8%). Driving forces include patent expirations of blockbuster biologics like Humira, Herceptin, and Remicade, coupled with a growing demand for cost-effective options in oncology, autoimmune conditions, diabetes, and chronic diseases?. Regionally, Europe leads the market, comprising ~45–46% share in 2023 at a valuation of $15–15.3?billion, supported by mature regulatory frameworks and proactive public policies. North America follows closely, with a U.S. market forecasted to be $22.6?billion in 2025, growing at a ~17% CAGR through 2034?. Asia?Pacific stands as the fastest-growing region, with market size approaching $2.9?billion in 2025 and a soaring CAGR of ~31–32%, fueled by rising healthcare access, manufacturing capabilities in India, China, and supportive government initiatives. Key trends include escalating competition among biosimilar developers, leading to price erosion and greater healthcare savings increased strategic partnerships, mergers, and acquisitions to bolster portfolios and capacities?; and expanding applications in oncology and chronic diseases, where biosimilars capture more than 80% of market volume post-launch.
Nevertheless, the industry faces challenges—including complex manufacturing processes requiring high capital investment, rigorous clinical and regulatory hurdles, legal/patent battles delaying entry, and residual provider hesitation around interchangeability and pharmacovigilance. Overall, the 7th Annual Congress will spotlight how biosimilars are rapidly transforming the global biologics landscape—offering enhanced access, cost savings, and clinical parity, while prompting stakeholders to adapt through innovation, strategic collaborations, and careful navigation of regulatory and operational barriers.
To Collaborate Scientific Professionals around the World
Conference Date April 27-28, 2026
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