AMCP Endorses Bipartisan Follow-On Biologics Legislation

Main Category: Biology / Biochemistry
Article Date: 24 Jun 2009 - 7:00 PDT

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The Academy of Managed Care Pharmacy (AMCP) has endorsed bipartisan legislation that would create a regulatory pathway for the approval of follow-on biologics and allow competition on brand-name biologics after five years of marketing exclusivity instead of the pharmaceutical industry's preferred 14-year window.

AMCP strongly supports H.R. 1427 and S. 729, the "Promoting Innovation and Access to Live-Savings Medicine Act of 2009," the Academy said in a June 22 letter to Rep. Henry Waxman (D-Calif.), Chairman of the House Energy and Commerce Committee, and Sen. Charles Schumer (D-N.Y.). Waxman and Schumer are lead sponsors of the respective bills.

Biologics are drugs made from living cells rather than chemical compounds. Brand-name biologics hold a virtual monopoly on the market because the U.S. Food and Drug Administration (FDA) currently lacks a regulatory pathway to approve less costly versions.

"Safe alternatives to some biologics have existed for more than 20 years," Judith Cahill, executive director of AMCP, said in the letter. "In anticipation of the expiration of patents for older biologic products and the new biologic products that are expected to come to market, and in recognition of the fact that these products are often prohibitively expensive, it is imperative that Congress address this issue," she added.

According to the legislation, a five-year window of marketing exclusivity would not begin at the time of the bill's enactment, but rather from the time when the brand-name drug was first approved. In the case of some biologics that have been on the market for 20 years with no competition, drug manufacturers would be able to seek approval for their follow-on versions "right away," according to a release posted on Schumer's website.

AMCP notes that the field of biotechnology holds great promise for the development of new therapies to prevent, treat or cure disease. At the same time, biologics are consuming an ever larger percentage of overall spending on prescription drugs, often putting them out of reach of patients, the Academy adds. AMCP supports an expedited review process by the FDA, but one that recognizes there are potentially significant differences between a follow-on biologic product and a generic chemical drug.

"With respect to the issue of interchangeability, AMCP believes that any determination of interchangeability by the FDA should be available to, but not binding on, managed care organizations and pharmacy and therapeutic committees in their assessment as to the use of follow-on biologic products in the development of their formularies," the Academy said.

AMCP believes the federal government should provide incentives to encourage innovator companies to pursue the development of safe and effective biologics while encouraging competition to ensure a robust marketplace. "The approach taken in your legislation appears to be consistent in meeting these objectives," Cahill told the lawmakers in the letter.

Source
Academy of Managed Care Pharmacy