On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the...more
On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”) intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order, among other things, encourages the...more
As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their...more
The U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) (collectively, the “Agencies”) have a long history of teaming up to ensure that advertising and other promotional communications for...more
The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more
On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more
Today 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...more
The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...more