The biosimilar landscape is growing, but the FDA should leverage analytical data to efficiently determine the quality of these products and propel them toward approval, according to a session at the Academy of Managed Care Pharmacy’s Nexus 2023 conference.
Results of a recent systematic review demonstrated no difference in the immunogenicity rates and safety profiles in patients who switched to a biosimilar and those who continued to receive the reference product.
An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.