Health reform bills would set approval path for generic biologics

Washington -- The two national health system reform bills would provide a first-ever approval process for generic biopharmaceuticals. But the bills also would give more protection to original biologic drugs than that supported by the Federal Trade Commission and proposed by President Obama's 2010 budget.

Both the House-adopted health system reform bill and the Senate measure under debate would give brand-name manufacturers of biologic drugs at least 12 years before a competitor could introduce generic versions of the medications. But an FTC report released in June concluded that providing 12 or more years of protection was unnecessary.

The difficulty of producing, obtaining approval for and marketing generic biologics -- often called biosimilars or follow-ons -- would naturally limit competition with original biologic drugs, the commission concluded. Obama's budget called on Congress to adopt legislation allowing generic biologics to enter the market seven years after the launch of the original drug.

The Food and Drug Administration has had an approval process for chemical generic drugs since 1984. There has been no such pathway for generic biologics, which have been approved by the FDA on an ad-hoc basis.

Biotechnology Industry Organization President and CEO Jim Greenwood said in a statement that the two major bills "strike the appropriate balance among ensuring patient safety, expanding competition, reducing costs, and providing necessary and fair incentives that will provide for continued biomedical innovation." The House adopted the Affordable Health Care for America Act on Nov. 7. The Senate began debating the Patient Protection and Affordable Health Care Act on Nov. 30.

But generic drugmakers rejected the moves. "In the name of true health care reform, it is incumbent upon Congress to strip the anti-consumer biologic provision out of health care reform," said Generic Pharmaceutical Assn. President and CEO Kathleen Jaeger.

The Senate bill also might allow brand-name biologic drugmakers to secure an additional 12 years of exclusivity by modifying the original drug slightly, according to Jaeger and the National Legislative Assn. on Prescription Drug Prices, an organization of state legislators that researches prescription drug prices and related legislation.