With just one week to go before some protein products in the US undergo a major regulatory transition 10 years in the making, uncertainties remain as to exactly what products will make the switch, when their patent and exclusivity information will be removed from the “Orange Book,” and the impact on currently marketed “authorized generics” of branded insulin products.
On 23 March, insulin, human growth hormone and certain other types of protein products that traditionally have been regulated as drugs will be “deemed” licensed biologics under the Public Health...