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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Law360 published an article on August 18, 2018, by Morgan Lewis life sciences lawyers that discusses the FDA’s plans to advance biosimilar products. In an effort to reduce the cost of prescription drugs, the Biosimilars Action Plan (BAP) focuses on four key strategies:  (1) improving the efficiency of the biosimilar and interchangeable product development and approval process; (2) maximizing scientific and regulatory clarity for the biosimilar product development community; (3) developing effective communications to improve understanding of biosimilars among patients, providers, and payors; and (4) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products. As discussed in the article, the BAP outlines several priority deliverables to achieve each strategy. Time will tell, however, if the BAP is able to achieve its goal of facilitating biosimilar development and promoting biosimilar use.

Read the full Law360 Article.