Biosimilars: new promise for reducing healthcare costs

After much anticipation, approval of the first U.S. biosimilar medications may be around the corner. Biosimilars hold the promise of reducing healthcare spending by offering lower-cost alternatives to highpriced biologic drugs. Biosimilars are not generic versions of existing biologics, however. Generic medications contain an active ingredient identical to that in the reference (‘‘brandname’’) product. A biosimilar may contain an active ingredient slightly different from the reference product, as long as the differences are not clinically meaningful. The Food and Drug Administration (FDA) describes a biosimilar as highly similar to the reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product. [1] .