Biologic medicines—drugs with complex molecules developed in living cells—have saved lives and improved the quality of life for millions of Americans. Yet despite their value, problems in the industry are driving up the cost of these already expensive medicines.
Just as less complex drugs have generic versions, biologics have biosimilars. But despite the fact they are just as safe and cost less biosimilars are rarely actually dispensed to patients. One barrier to biosimilar uptake is perception. Despite extensive evidence of safety and efficacy, many physicians have been slow to embrace biosimilars. The Food and Drug Administration (FDA) can help address this in a couple of ways. First it can help to increase public awareness—and physician awareness—of the safety and efficacy of biosimilars. In particular, focus should be put on the fact that biosimilars are no more different from the reference product than one branded batch is from another.
Each batch of biologic medicine has slight variations, even when produced by the same company. For a biosimilar to receive FDA approval it must be manufactured to the same standards as any batch of the original product.
Justin Leventhal is a senior policy analyst for the American Consumer Institute, a nonprofit education and research organization. For more information about the Institute, visit www.TheAmericanConsumer.Org or follow us on X @ConsumerPal.