Okeya James
As the patents for blockbuster biologic drugs expire, biosimilars— biologic medicines that are highly similar to existing reference products— are poised to reshape the pharmaceutical landscape. Offering comparable efficacy and safety at reduced costs, biosimilars present a compelling opportunity to expand access to life-saving treatments. However, their path to market is fraught with regulatory, scientific, and commercial challenges. Licensing biosimilars effectively requires navigating a complex web of global standards, market dynamics, and evolving technologies.
