Potential for health care savings drives increased interest in generic biologics
Two competing proposals have recently been introduced to help establish a regulatory pathway for the approval of generic biologics. They are at odds primarily over the time period of data exclusivity that drug manufacturers should be permitted.
Rep. Henry Waxman (D-Calif.), the chair of the Energy and Commerce Committee has introduced the Promoting Innovation and Access to Lifesaving Medicines Act (H.R. 1427). Senators Chuck Schumer (D-N.Y.), Susan Collins (R-Maine), Sherrod Brown (D-Ohio), and Mel Martinez (R-Fla.) have sponsored a companion measure in the Senate, (S. 726). The bill would grant brand-name companies five years of exclusivity, plus an optional three-year extension for modified versions and an additional six months if the manufacturer conducts a pediatric study on the drug.
A separate proposal has also been introduced by Rep. Anna Eshoo (D-Calif.), Rep. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, and Rep. Jay Inslee (D-Wash.). The Pathway to Biosimilars Act (H.R. 1548) would grant brand-name biologic drug makers a 12-year period of exclusivity.
Biologics, also referred to as biopharmaceuticals, are expected to account for nearly half of all approved pharmaceuticals in the U.S. in the coming year or so. They are also among the most expensive drugs and are most commonly used for the treatment of patients with cancer.
The original patents on many of these drugs are beginning to expire, prompting action by Members of Congress to help establish a framework by which lower-cost generic biologic therapies can be safely and accurately replicated and advanced to patients.
While the 1984 Hatch-Waxman Act governs the pathway for traditional generic pharmaceutical drugs, it cannot be applied to biologics, which are more structurally complex because they are derived from proteins manufactured in living cells and, therefore, cannot be reproduced exactly.
Establishing a pathway for biologics has become particularly significant to lawmakers recently as they search for methods to control health care costs. President Obama recently prioritized generic biologics in his FY2010 budget outline as a way to address the high cost of prescription drugs.
Read More from the April Edition of the AACR Cancer Policy Monitor: