Real-world evidence (RWE) can serve as a “key complement” in clinical studies and help foster the growth of biosimilars in the U.S. market, according to a recent article published on Clinical Leader.
“For example, RWE can demonstrate that, in practice, a healthcare product’s disease management and safety do not change significantly from brand-name biologic drug to biosimilar,” the authors, DIA’s Sandra Blumenrath and Ranjini Prithviraj, write.
RWE has the potential to ease concerns about the effectiveness of biosimilars against their brand-name equivalent by offering a better picture of both performance and disease management.
“As biosimilars face cultural resistance from large parts of the patient population, there are lessons to be learned from how Europe has tackled the biosimilars issue and made it culturally (and economically) attractive to increase the number of biosimilars on the market,” Blumenrath and Prithviraj write.
As of December, the U.S. has only approved nine biosimilar products, while Europe has given to green light to 33 products.