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By Lisa P. Rumin, Jon B. Dubrow and McDermott Will & Emery on Feb 5, 2020
Posted In FDA, Life Sciences
This blog was originally published on McDermott’s Antitrust Alert Blog. On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional...
FTC to Look Closely at Competition between Biologics and Biosimilars and Patent Protection Strategies of Branded Manufacturers
By Louise Aberg and McDermott Will & Emery on Jul 24, 2018
Posted In FDA, Health Antitrust
WHAT HAPPENED On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC, discussing how to bolster competition from biosimilars while maintaining innovation. The Commissioner noted the absence of true competition among biologics from biosimilar products in the United States, similarly to what...