US legislation for FDA approval of follow-on biologics: competing bipartisan proposals

The debate in the US Congress over the approval of follow-on biotechnology drugs has become more complicated by the presence of  competing bills presented to the House of Representatives. First to be  introduced were proposals by Rep Henry Waxman (Democrat, California),  the Chairman of the House Energy and Commerce Committee who was also one  of the architects of the Hatch-Waxman Act of 1984 which established the  current system for generic drug reviews (Marketletters passim).

His new bill, the Promoting Innovation and Access to Life-Saving  Medicine Act (HR1427; Marketletter March 23), is also supported by Reps  Frank Pallone (Democrat, New Jersey), Nathan Deal (Republican, Georgia)  and Jo Ann Emerson (Republican, Missouri). Biotechnology drugs would  receive five years of freedom from generic competition, except in some  cases, where an extra three years could be awarded by the Food and Drug  Administration for new improvements and indications. HR1427 is  enthusiastically supported by the Generic Pharmaceutical Association  (GPhA), some health care payers, labor unions and consumer groups.

By contrast the Pathway for Biosimilars Act (HR1548), proposed by Reps  Anna Eshoo (Democrat, California), Jay Inslee (Democrat, Washington) and  Joe Barton (Republican, Texas), "creates a process for approval of  'biosimilars' or 'follow-on biologics' while protecting patient health  and safety, lowering health care costs and providing adequate  incentives for innovation," the bill states.