Why DSC Testing Is A Critical Step In Developing Biosimilar Drugs

By Calliste Scholl

Biologic therapies derived from living organisms have transformed the treatment of complex diseases, but their development comes with high costs that are often passed on to patients. Biosimilar drugs present a promising option for reducing these costs while still providing effective treatment. However, unlike generic drugs, biosimilars cannot be exact duplicates of their reference biologics due to their intricate structures, which require extensive testing and regulatory approval. Microcalorimetry, particularly Differential Scanning Calorimetry (DSC), plays a vital role in this process by evaluating the thermal stability of biosimilars to confirm they are structurally similar and perform comparably to their reference drugs. Explore the importance of testing in the regulatory process and how tools like DSC are helping to bring more biosimilars to patients in need.