Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill

Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application approval pathway for biological products – so-called “generic biologics,” “follow-on biologics,” or “biogenerics.”

According to the summary of the proposed bill, a generic biological product is “comparable,” and therefore approvable in an abbreviated application, “if there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product, based on non-clinical studies and clinical studies, as necessary.”

Click here to access Rep. Waxman’s website, which includes a press release, background information on biologics, a quick summary of the bill, a full bill summary, the text of the bill, and letters of support.