The Campaign for Sustainable Rx Pricing, of which the AHA is a founding member, today joined more than a dozen other health organizations in urging the Food and Drug Administration to finalize guidance critical to increasing competition in the biologics marketplace and expanding access to more affordable biosimilar options, similar to the generic options that exist today for molecule drugs. While a small population of patients use biologic drugs, they account for more than 40 percent of prescription drug spending – in large part because of additional regulatory hurdles that discourage developers from introducing biosimilars. The groups said that guidance would improve FDA's approval of lower cost options for the patients who rely on costly biologic drugs – a focus of the FDA’s Biosimilars Action Plan, which was introduced last month as one of the Administration’s efforts to address out-of-control drug prices. “We are very hopeful that this guidance will increase access to affordable biological products and strongly urge the FDA to finalize it as soon as possible,” the groups wrote.

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