Issue 9 - Mirror, Mirror on the Wall, How to Characterize Biosimilars for All?
Octet?- Affinity, Binding Kinetics and Concentration
Label-Free, Stress-Free Solutions for Drug Discovery and Biologics
The increasing demand for affordable drugs has propelled the growth of the biosimilar market. Biosimilars offer a cost-effective alternative to expensive biologics, making advanced treatments more accessible to patients worldwide. However, the development of biosimilars is fraught with challenges, primarily due to the complex nature of biological products. As the biosimilar market is set to exceed 100 billion USD by 2028, the need for meticulous testing to ensure these products meet high standards of quality, safety, and efficacy has never been more critical.
Meeting regulatory requirements is crucial for the successful approval and market entry of biosimilars.
Advanced analytical techniques are at the heart of biosimilar characterization, with complementary orthogonal techniques playing a pivotal role. These include biosensor-based ligand binding assays and cell-based analysis.
Additionally, Vivaspin? and Vivaflow? Ultrafiltration Devices are crucial for the concentration and purification of biosimilars, while the Incucyte? Live-Cell Analysis System enables real-time analysis of live cells.
The ICH Q2(R2) publication provides guidance on validating analytical technologies, detailing parameters such as specificity, accuracy, and precision that must be assessed during method development and validation. Since the launch of the first biosimilar in 2015, the FDA and EMA have approved numerous biosimilars, with many more expected as patents expire by 2030.
Regulatory agencies like the EMA, FDA, and WHO require rigorous comparability studies to demonstrate biosimilarity, ensuring no clinically meaningful differences in safety, purity, and potency between biosimilars and their reference products.
This process involves comprehensive analytical characterization, including biophysical and cell-based assays, often requiring advanced and costly instrumentation and reagents. The approval of biosimilars follows an abbreviated licensure pathway, underpinned by thorough comparability studies and the assessment of critical quality attributes throughout the development and manufacturing process.
Emphasizing the importance of affinity and kinetics characterization, this document provides practical insights and detailed examples, such as a typical binding kinetics experiment utilizing BLI in a label-free and real-time manner.
Whether involved in R&D, regulatory affairs, or quality control, this white paper offers invaluable insights and practical examples to enhance your biosimilar development strategies.
Download our whitepaper now to stay at the forefront of biosimilar innovation!
Publication search made easy!
Finding new, impactful studies is a critical part of advancing the field—but also time-consuming to do. We’ve developed an easy search tool to help scientists find relevant publications that use Octet? BLI systems and assays.
Access the tool now to see the versatility and effectiveness of this platform in infectious disease research and beyond.
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More Application Insights
Discover some recently released publications.
Infographic: Developing Biosimilars: Challenges and Solutions
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