Editorial - (2025) Volume 11, Issue 3
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.
Abstract
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.
Published: 26-Sep-2025, DOI: 10.35248/2471-268X.24.11(3).005
Copyright:This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
