One of the most promising frontiers in healthcare is biologic medicines — complex substances derived from living cells that can help fight chronic diseases and cancers. To encourage investment in biologics, Congress in 2010 gave drug companies what amounts to a 12-year monopoly on the substances they developed. Now, supporters of biologics are pushing lawmakers in Sacramento and other state capitals to put new hurdles in the way of knock-off compounds, called "biosimilars."
The debate over biosimilars is grounded in doubts about their safety; none have yet been approved for use in the United States. Proponents of a bill by California Sen. Jerry Hill (D-San Mateo) to regulate the dispensing of biosimilars include critically ill patients who fear that the new medicines won't match the biologics they rely on, as well as doctors who prescribe and study biologics. Supporters also include the biotechnology companies whose expensive biologics account for about a quarter of U.S. pharmaceutical revenue — a share that's expected to reach $100 billion in 2015.
On the other side stand the generic drug companies that want to make biosimilars. They see measures like Hill's as a thinly veiled attempt by leading biologic manufacturers Amgen andGenentech to hold off competition. They've won support from U.S. Food and Drug Administration CommissionerMargaret Hamburg, who warned against reducing the public's confidence in biosimilars. She recently predicted that competition from biosimilars would "spur innovation, improve consumer choice and drive down medical costs," just as the generic versions of brand-name pills have done.
Clearly, patient safety has to be policymakers' top priority. But state lawmakers shouldn't substitute their own judgment for the FDA's scientific analysis. And they need to balance the very real needs of the patients taking biologics against the public's interest in affordable healthcare. That's why they should be wary of impeding the arrival of biosimilars that the FDA deems interchangeable with their biologic counterparts.
Continue Reading here