RE:RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse events The IRA mandates that certain small molecule drugs be subject to Medicare drug-pricing negotiations after nine years, while biologics can enjoy 13 years on the market before they’re up for price reductions.
AZ argued its Merck-partnered cancer drug Lynparza is one example of how the IRA's framework is flawed. Lynparza is a small molecule PARP inhibitor.
Today a federal court judge in Delaware ruled in favor of the IRA whereby biologics are given 13 years of market exclusivity in contrast to nine years for small molecules.