Biosimilars & Biotechnology: Making Advanced Therapies Accessible
"Explore how modern biotech drives the development of safe, effective, and affordable biologic medicines."
What Are Biosimilars?
Biosimilars are cutting-edge biotech medicines designed to closely match original biologic drugs. Developed using living cells and advanced analytics, they offer safe and cost-effective alternatives in areas like cancer and autoimmune disease.
Near-term economic impact includes biosimilars sooner or later for the ~45, nearly all recombinant, mostly monoclonal antibody, products with over $1 billion/year sales, and 20+ others with sales over $500 million/year.
The Role of Biotechnology
The Science Behind Biosimilars
The development of biosimilars relies heavily on advanced biotechnology, starting with the use of genetically engineered cells such as mammalian or bacterial systems modified to produce therapeutic proteins identical to those in reference biologics. These cells synthesize complex proteins that must undergo precise folding and post-translational modifications to ensure correct structure and function. Once produced, the proteins are extracted through a series of controlled bioprocessing and purification techniques, including filtration and chromatography, to isolate and concentrate the active ingredient. Throughout this process, sophisticated quality control tools such as mass spectrometry, bioassays, and structural analyses are employed to confirm that the biosimilar matches the originator in safety, purity, and efficacy.
Why Biosimilars Matter?
Affordable Innovation for Global Health
Biosimilars play a critical role in modern healthcare by significantly improving patient access to life-saving treatments that were previously limited by the high cost of original biologics. By offering clinically equivalent alternatives at lower prices, biosimilars help reduce the financial burden on healthcare systems, allowing more patients to receive timely and effective therapies for chronic and life-threatening conditions such as cancer, diabetes, and autoimmune diseases. Their introduction also supports greater availability in low- and middle-income countries, where access to advanced biologic treatments has traditionally been constrained by affordability and infrastructure. Moreover, by easing the economic pressure associated with biologic drugs, biosimilars contribute to the sustainability of biologic therapy pipelines, ensuring long-term investment in innovation while maintaining broad access across global populations.
Future Manufacturing Strategies for Biosimilars
The development and availability of biosimilars vary across the globe, with an increasing number of region-specific approvals reflecting diverse regulatory environments and healthcare priorities. In highly regulated markets such as the United States, the European Union, and parts of Asia, biosimilars are now widely accepted and approved for multiple therapeutic areas, including oncology, rheumatology, and endocrinology. Alongside these approvals, a significant number of biosimilar candidates are currently in clinical trials, aiming to expand treatment options and improve access to biologics as patents on originator products expire. These trials focus on demonstrating similarity in safety, efficacy, and immunogenicity compared to the reference drugs. Driving this global momentum are innovative biotechnology companies that lead in the research, development, and manufacturing of biosimilars. Through advanced bioprocessing technologies and rigorous analytical testing, these companies are not only ensuring product quality and regulatory compliance but are also helping to shape a more sustainable and equitable future for biologic therapies.
Resolving biosimilar manufacturing-related uncertainties
Despite widespread anecdotal evidence of developer and CMO involvement, there is still no comprehensive data on how biosimilars are being developed and manufactured, particularly concerning future approaches. Key questions remain unresolved: the extent and timing of CMO engagement, whether companies will prioritize early development support or full-scale commercial manufacturing, and how production will be distributed between in-house facilities and external partners. Additional uncertainties involve the choice of manufacturing technologies such as single-use systems, stainless steel, hybrid setups, or continuous processing methods and whether biosimilar production will follow modern, state-of-the-art standards or replicate legacy processes. The selection of expression systems and facility designs also reflects strategic decisions tied to efficiency, scalability, and regulatory compliance. To address these unknowns, ongoing efforts are focused on expanding biosimilar development and manufacturing databases, aiming to clarify the evolving landscape. As the industry continues to advance, CMOs with flexible and efficient capabilities are expected to play an increasingly strategic role in shaping the future of biosimilar bioprocessing.
Pipeline & Progress
Tracking the Global Biosimilar Pipeline : Show interactive visuals or updates on :
The global landscape of biosimilars is rapidly evolving, with a growing number of biosimilars approved across different regions such as North America, Europe, and Asia, reflecting the expanding regulatory frameworks and market acceptance worldwide. Regulatory agencies like the FDA and EMA have approved numerous biosimilars for critical therapeutic areas, enabling wider patient access to affordable biologic treatments. Meanwhile, a robust pipeline of biosimilars currently in clinical trials continues to advance, targeting new indications and improving on existing therapies, which demonstrates ongoing innovation and commitment to expanding the biosimilar portfolio. At the forefront of this progress are pioneering biotechnology companies that invest heavily in research and development, employing cutting-edge techniques in genetic engineering, protein analysis, and bioprocessing to create high-quality biosimilars and biobetters. These industry leaders drive not only product innovation but also improvements in manufacturing efficiency and regulatory strategy, shaping the future of accessible biologic medicines.
Biosimilars: Approval Process
This video provides a comprehensive overview of the biosimilar approval process, highlighting all essential steps required by regulatory agencies. It covers the rigorous analytical comparisons, non-clinical evaluations, clinical trials, and quality standards used to ensure biosimilars are as safe and effective as the original biologics. From molecular characterisation to immunogenicity assessment, every stage of the regulatory pathway is explained, offering clear insight into how biosimilars gain approval for clinical use.
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