Capitol Hill Watch | House Democrats Introduce Legislation That Would Allow FDA To Approve Follow-on Biologics - Kaisernetwork.org

"Reps. Jay Inslee (D-Wash.), Gene Green (D-Texas) and Tammy Baldwin (D-Wis.) on Thursday introduced legislation (HR 1956) that would allow FDA to approve follow-on biologics, CQ HealthBeat reports. Follow-on biologics are lower-cost versions of biotechnology drugs. FDA has no approval process for follow-on biologics. Under the measure introduced Thursday, drug makers would receive 14 years of data exclusivity for new follow-on biologics, with the possibility of an additional year if the HHS secretary approved the drug for a new indication that offered a "significant clinical benefit" during the 12 years following its authorization. The measure would allow the HHS secretary to issue guidance describing the data that would be required for approval of follow-on biologics in a particular class. The measure also would allow FDA to make a science-based determination about the data and information needed for approval of such drugs, including factors such as complexity and immunogenic reactions of the original product. In addition, FDA would be permitted to request comment from patient groups, brand-name drug manufacturers and generic manufacturers throughout the approval process. To ensure the safety of such drugs, FDA would be allowed to request nonclinical studies and clinical trials "at appropriate levels," according to the legislation."