FDA releases biosimilars draft guidances
Documents are first step in expedited pathway for generic biotech drugs
March 26, 2012 at 08:00 PM
18 minute read
In the small-molecule drug area, which covers chemical drugs, the Food & Drug Administration (FDA) has provided generic drug makers with an expedited approval process—and incentives for companies to take advantage of them—since the 1984 Hatch-Waxman Act. The pathway changed the market, creating a generic drug industry that in 2011 accounted for more than 70 percent of all prescriptions in the U.S., according to IMS Health, a pharmaceutical intelligence company.
Hatch-Waxman didn't cover the $30 billion biological products market, however. Biologics are drugs and treatments that are far more complex than small-molecule drugs. They require much more complicated manufacturing processes and often are derived from living cells or tissues. The most widely used biologics treat diabetes, cancer, rheumatoid arthritis and multiple sclerosis. When a drug has no clinically meaningful difference from a reference product, it is biosimilar.
But there was no abbreviated FDA approval pathway for biosimilars until the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted on March 23, 2010, as part of the Patient Protection and Affordable Care Act.
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