Number 5: July brought much discussion about biosimilar policies in the U.S. and abroad, as well as three highly anticipated FDA approvals.
Number 4: In addition to the overall drug price inflation of 3.81% forecast for 2025, several originator biologics that will face competition from biosimilars in the coming years are expected to increase their list prices, according to Vizients Pharmacy Market Outlook Report for Summer 2024.
Number 3: According to a recent study, value-based healthcare strategies in Singapore’s public institutions have significantly increased the use of biosimilars, resulting in lower treatment costs and significant savings for the healthcare system.
Number 2: The variety of biologic drugs available today has helped countless patients manage diseases where conventional treatments have not been satisfactory. Individuals with autoimmune diseases, cancer and diabetes have benefited, as have those with previously untreatable genetic diseases. The most complex biologics first came to market in the 1980s and 1990s, and because of this, many of their patents are expiring. The concept of biosimilars was a common sense idea that loosely mimicked the idea of generics. However, because biologics are large, three-dimensional and complex molecules, it took time for regulators around the world to develop appropriate regulations.
Number 1: FDA’s new guideline for glycan profiling of monoclonal antibodies (MAbs) receives praise and recommendations from Sarfaraz K. Niazi, PhD.
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