Big pharma backs a rule that would stifle competition from companies that make low-cost ‘biosimilars’
A DIFFERENT WAY: Biologics are drugs developed using DNA technology and grown within plant or animal cells. Unlike traditional drugs, which combine different chemicals to create medicines, biologics must be developed through organic growth.
By Erik Telford
What’s in a name? As far as affordable access to lifesaving drugs is concerned, plenty.
Unfortunately, big pharmaceutical companies, their lobbyists and the special interests on their payroll are working to convince the Food and Drug Administration to stifle the competition by imposing a new naming rule that could cost consumers, in both dollars and health outcomes.
Biologics are drugs developed using DNA technology and grown within plant or animal cells. Unlike traditional drugs, which combine different chemicals to create medicines, biologics must be developed through organic growth. The DNA technology is cutting-edge, but biological medicine is as old as the prehistoric use of herbs.
Biologics are similar to traditional drugs, though, in that they, too, have been followed by generic equivalents. “Biosimilars,” as the biologics’ equivalents are called, cost much less and would provide strong competition in the free market. Such competition could lower costs by up to 40 percent, according to the Congressional Budget Office.
However, the FDA, in league with special interests, has slow-rolled its approval of biosimilars. FDA’s inaction could keep biosimilars out of the U.S. marketplace altogether, even though the European Union approved their sale more than a decade ago. Well-funded groups that have the FDA’s ear argue that the process that creates biologic medicines is too complex to allow for equivalents, and that any change in the manufacturing process creates an entirely new drug with different healing properties and effects — necessitating unique names.
