Senate panel approves bill for generic biologics

Washington -- Five senators have crafted a bipartisan bill creating a pathway for generic biopharmaceuticals.

The Biologics Price Competition and Innovation Act of 2007 would grant original makers of biological drugs -- those made from living organsms or its products -- 12 years of exclusive marketing.

The measure would allow generic producers to apply to the Food and Drug Administration to produce generic biologics that are either "biosimilar," which means they show no meaningful clinical differences to the original, or "interchangeable," which means the drug can be substituted for the original without the approval of a physician.

The Senate Health, Education, Labor and Pensions Committee, chaired by the bill's sponsor, Sen. Edward Kennedy (D, Mass.), approved the measure June 27. It is co-sponsored by Sens. Hillary Rodham Clinton (D, N.Y.), Charles Schumer (D, N.Y.), Orrin Hatch (R, Utah) and Mike Enzi (R, Wyo.). "Just as generic drugs have helped bring down the costs of medicines for millions of Americans, new 'follow-on' versions of breakthrough biologics will make these innovative treatments more affordable," Kennedy said.

Instead of moving the bill to the full Senate, Kennedy plans to include it in an anticipated conference committee for the Prescription Drug User Fee Act, which would update the FDA's drug approval authority. The Senate passed PDUFA 93-1 in May. The House is expected to take up the measure this month.

Rep. Henry Waxman (D, Calif.) introduced a bill in February to create an abbreviated approval process for generic biologics, but it contains no exclusive marketing provision for brand-name biologic drugmakers. The future of Waxman's bill was unclear as of press time.

The AMA has not taken a position on the bills. Both the trade group, Biotechnology Industry Organization, and the Generic Pharmaceutical Assn. would like to see some provisions in the Senate bill changed. BIO advocates for 14 years of exclusive marketing, in order to better recoup research and development costs.

However, the GPA believes 12 years is too long for consumers to wait for generic biologics. The European Union provides 10 years of patent protection to new biologics, said spokeswoman Andrea Hofelich.

BIO is also concerned about the Senate bill's provision allowing generics approved as interchangeable to be purchased without physician approval. This would undermine the patient-doctor relationship, said spokesman Jeff Joseph.