Governors petition FDA to allow biosimilars

The governors of four states are pressing the FDA to clarify how generic drug makers can start making biosimilar therapies. Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston, told The Boston Globe that the petition creates significant political pressure to force the agency to lay out a regulatory pathway for generic biologics. It's a huge issue for the industry. Biologics with an estimated $50 billion in sales are losing patent protection over the next three years. And up to now the FDA has resisted spelling out how generic companies can step in. Biotech companies are insisting that biologics, unlike traditional meds, are simply too complex to permit generic successors. But with the price of biotech drugs soaring, pressure continues to build for a major change in approach.

- read the article on the petition from The Boston Globe