Biosimilars: Introduction, Concerns, and Opportunities

Discussion and resolution of the various scientific and regulatory factors behind approval of biosimilars is perhaps one of the most significant events in the last decade for biotechnology. The regulators have the daunting task of maintaining the balance between the financial benefit from allowing approval of biosimilars and the safety of the patients. Now that the U.S. Congress has passed a law allowing biosimilars, we look forward to the timely but responsible creation of a regulatory process that can bring them to the U.S. market.