Program on Regulation, Therapeutics, and Law (PORTAL) reposted this
Assistant Professor of Health Policy at The London School of Economics and Political Science (LSE)
Biologics receive greater legal protections in the US than small-molecule drugs. In a new JAMA study, we analyzed whether these protections are justified. Biologics represent 2% of prescriptions in the US but tend to be more expensive and account for approximately half of total drug spending. They receive longer periods of market exclusivity and protection from price negotiation than small-molecule drugs. The justification has been that biologic developers need more protections to recoup their development costs. We found no evidence supporting this differential treatment. Biologics had higher clinical trial success rates than small-molecule drugs at each phase of development and similar development times and costs. Biologics were also protected by many more patents and generated substantially higher revenues. These results call into question the need for policies that protect biologics from competition or price negotiation for longer periods than small-molecule drugs. US law appears to overly reward the development of biologics relative to small-molecule drugs. Matthew Vogel, William Feldman, MD, DPhil, MPH, Reed Beall, Aaron S. Kesselheim, M.D., J.D., M.P.H., S. Sean Tu https://lnkd.in/eRuT_6bF
