Shorter Exclusivity Could Carry a Hefty Price Tag
If successful, efforts to reduce the 12 years of data exclusivity granted under the Affordable Care Act for innovative biologics could prove to be costly for patients, payers and the companies that make the drugs.
Reducing data exclusivity to seven years, as the president and a number of lawmakers have proposed, would be disruptive to the marketplace as it would encourage at-risk launches of biosimilars and lead to unnecessary patent litigation, said Dave Fox, former associate chief counsel for drugs at the FDA and a partner at Hogan Lovells.
Suite: 1100 | Atlanta, Georgia 30346, USA
In the U.S. and Canada: 1-800-477-6307
Outside the U.S.: 1-770-810-3144
In the U.S. and Canada: 1-800-336-4474
Outside the U.S.: 1-215-386-0100
Hours: Monday - Friday, 8:00am - 6:00 pm EST
Sign up for Highlights FREE e-mail newsletter