Biosimilar Development

Biologic therapeutics have revolutionized the treatment of cancer and immune-mediated inflammatory diseases. As patent protections on innovator biologics expire, global drug manufacturers are ramping up the development of follow-on drugs known as biosimilars. These therapeutic agents are highly similar to the original patented biologic in structure and function.

The process of manufacturing innovator biologic and biosimilar drugs is complex and variable; thus robust characterization tools are needed. Biosimilar development, in particular, requires extensive analytical comparison of drug structure and function to ensure biosimilarity to the reference product. We offer a variety of analytical tools that enable drug developers to bring these biosimilar products to market, thereby ensuring patient access to high-quality, cost-effective therapeutics.