World Congress on
Biologics and Biosimilars

Biosimilars and biologics are advanced therapies derived from living organisms, offering targeted treatment for complex diseases such as cancer, autoimmune disorders, and diabetes. Biologics are original large-molecule drugs developed through biotechnology, while biosimilars are highly similar versions of approved biologics, with no significant differences in safety or effectiveness. Biosimilars undergo rigorous testing to ensure their quality and are more cost-effective, increasing patient access to life-saving treatments. As patents for many biologics expire, biosimilars provide a competitive alternative, driving innovation and reducing healthcare costs. Together, biologics and biosimilars are transforming modern medicine and expanding treatment options worldwide.

Developing biosimilars presents several challenges due to the complexity of biologic medicines. Unlike generic drugs, biosimilars cannot be exact copies, making it essential to demonstrate high similarity through extensive analytical, preclinical, and clinical studies. Manufacturing is technically demanding, as slight variations can impact safety and efficacy. Regulatory pathways vary globally, adding complexity for developers aiming for international approval. Additionally, gaining physician and patient trust remains a hurdle due to misconceptions about biosimilar effectiveness. Market competition, intellectual property barriers, and pricing pressures further complicate development. Overcoming these challenges requires collaboration, education, and regulatory harmonization to ensure wider adoption and accessibility.

Intellectual Property Rights (IPR) are legal protections granted to creators and innovators to safeguard their inventions, designs, and artistic works. In the pharmaceutical industry, IPR—particularly patents—play a crucial role in encouraging innovation by granting exclusive rights to manufacture and market new drugs for a set period. This exclusivity allows companies to recover research and development investments. However, IPR can also delay the entry of cost-effective alternatives like biosimilars into the market. Balancing innovation incentives with public access to affordable medicines is a key global challenge. Effective IPR management ensures fair competition, fosters innovation, and protects the interests of stakeholders.

Biomarkers are measurable indicators of biological processes, disease states, or responses to treatment, playing a vital role in medical research and personalized medicine. They help in early diagnosis, monitoring disease progression, predicting treatment outcomes, and identifying patient subgroups likely to benefit from specific therapies. In biosimilar and biologic drug development, biomarkers are used to assess pharmacodynamic responses, guide clinical trial design, and ensure therapeutic equivalence. Advances in genomics, proteomics, and bioinformatics have expanded biomarker discovery, driving more targeted and efficient research. As a result, biomarkers are transforming healthcare by enabling more precise, individualized treatment strategies and improving overall patient outcomes.

Biological medicine, or biologics, refers to a class of drugs derived from living organisms or their cells using advanced biotechnology. Unlike chemically synthesized drugs, biologics are large, complex molecules such as proteins, antibodies, or vaccines that target specific components of the body’s immune or cellular systems. They are used to treat a wide range of conditions, including cancer, autoimmune diseases, and rare genetic disorders. Biologics have revolutionized modern medicine by offering highly effective, targeted therapies. However, their development and manufacturing are complex and costly, requiring stringent quality control and regulatory oversight to ensure safety, efficacy, and consistency in patient care.

Brexit has had a significant impact on the pharmaceutical and biosimilar industries, particularly in regulatory alignment, trade, and workforce mobility. The UK’s departure from the European Union created uncertainty around the approval and distribution of medicines, as the UK no longer falls under the European Medicines Agency (EMA). Companies must now navigate separate regulatory pathways for the UK and EU, increasing administrative and financial burdens. Additionally, border delays and customs complexities have affected supply chains. The relocation of regulatory functions and skilled professionals to the EU has also created gaps in expertise, requiring strategic adjustments to maintain industry competitiveness.

Regulatory frameworks for biosimilars are evolving globally to enhance accessibility, streamline development, and align with scientific advancements. In the United States, the FDA has proposed eliminating the requirement for switching studies to demonstrate interchangeability between biosimilars and their reference products. This change aims to reduce development costs and expedite market entry, reflecting confidence in current analytical methods to assess biosimilarity. In Europe, the European Medicines Agency (EMA) is considering revisions to its guidelines, potentially reducing the need for extensive clinical trials by emphasizing analytical and functional data. A consultation on these changes is expected in 2025.

Biosimilars development is rapidly expanding across global markets due to increasing demand for affordable biologic therapies. Emerging markets like India, Brazil, and China are becoming key players, supported by evolving regulatory frameworks that encourage biosimilar approvals while ensuring safety and efficacy. In established markets such as the US and Europe, biosimilars are gaining traction through streamlined regulatory pathways and growing physician acceptance. Market growth is driven by patent expirations of major biologics, cost-containment pressures, and rising chronic disease prevalence. Despite challenges like manufacturing complexity and market competition, biosimilars are enhancing treatment accessibility and fostering innovation worldwide.

Biopharmaceutical informatics integrates data science, bioinformatics, and information technology to advance drug discovery, development, and manufacturing in the biopharmaceutical industry. By analyzing complex biological data, such as genomics, proteomics, and clinical trial results, it helps identify drug targets, optimize formulations, and predict patient responses. This interdisciplinary field enables more efficient biosimilar and biologic development by improving quality control, reducing costs, and accelerating regulatory submissions. Advanced computational tools and machine learning models support decision-making, risk assessment, and personalized medicine strategies. As biopharmaceuticals grow in complexity, informatics is essential for innovation, ensuring safer, more effective therapies reach patients faster.

The global biosimilars market is experiencing significant growth, driven by factors such as patent expirations of major biologics, increasing healthcare costs, and the demand for affordable treatment options. In 2025, the market is projected to reach approximately $35.04 billion, with a compound annual growth rate (CAGR) of 7.5% from 2025 to 2035. Biosimilars offer cost savings of up to 60% compared to their reference biologics, making them attractive alternatives for insurers, hospitals, and patients seeking lower-cost options. However, the development of biosimilars involves complex manufacturing processes and high costs, ranging from $100 million to $300 million per product, which can limit competition and market entry. Despite these challenges, the biosimilars market is expanding into specialized therapeutic areas such as ophthalmology and neurology, indicating a broader acceptance and integration of biosimilars into mainstream treatment protocols.

Challenges in biosimilars pharmacovigilance stem from their complex nature and the need for rigorous safety monitoring after approval. Since biosimilars are similar but not identical to original biologics, tracking adverse events requires precise identification to differentiate between products. Variations in naming conventions and substitution practices can complicate traceability. Additionally, limited real-world data and inconsistent reporting by healthcare providers hinder effective monitoring. Ensuring patient and provider awareness about the importance of reporting is crucial. Regulatory frameworks are still evolving to address these challenges, aiming to strengthen post-marketing surveillance and maintain confidence in biosimilar safety and efficacy worldwide.

The globalization of biosimilars is transforming healthcare by expanding access to affordable biologic therapies worldwide. As patents for original biologics expire, many countries are developing regulatory frameworks to encourage biosimilar approvals and market entry. This global expansion fosters competition, driving down costs and improving patient access, especially in emerging markets. However, challenges like varying regulatory standards, intellectual property issues, and manufacturing complexities require international collaboration and harmonization. Advances in technology and shared scientific knowledge are helping overcome these barriers, enabling biosimilars to play a crucial role in addressing global health disparities and supporting sustainable healthcare systems across diverse regions.

Drug delivery and development focus on creating effective methods to transport therapeutic agents safely and efficiently to targeted sites in the body. Advances in this field aim to improve drug stability, bioavailability, and patient compliance while minimizing side effects. Innovative delivery systems, such as nanoparticles, liposomes, and controlled-release formulations, are increasingly used in biologics and biosimilars to enhance treatment outcomes. During drug development, optimizing delivery strategies is crucial to meet regulatory requirements and ensure clinical efficacy. This multidisciplinary approach integrates chemistry, biology, and engineering, driving the creation of next-generation therapies that are more precise, effective, and patient-friendly.

AI and data analytics are revolutionizing biologic research by enabling faster, more accurate analysis of complex biological data. These technologies help identify novel drug targets, optimize molecular designs, and predict clinical outcomes with greater precision. Machine learning algorithms analyse vast datasets from genomics, proteomics, and clinical trials to uncover patterns and insights that were previously impossible to detect. AI-driven models accelerate biosimilar development by improving quality control and reducing the need for extensive animal and human testing. Overall, AI and data analytics enhance decision-making, reduce costs, and expedite the development of safer, more effective biologic therapies tailored to individual patient needs.

As of October 2024, the U.S. Food and Drug Administration (FDA) has approved 60 biosimilars, significantly expanding treatment options across various therapeutic areas, including oncology, immunology, and endocrinology. These biosimilars serve as highly similar versions of reference biologics, offering comparable safety and efficacy profiles at reduced costs. Notable recent approvals include Starjemza (ustekinumab-hmny) in May 2025, Jobevne (bevacizumab-nwgd) in April 2025, and Bomyntra (denosumab-bnht) in March 2025. The FDA's approval process ensures that these biosimilars meet rigorous standards, promoting competition and improving patient access to essential therapies.