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Biosimilars

Roche

Note from the editor

Ten biosimilars, the copycat versions of drugs like Humira and Enbrel, were approved by the Food and Drug Administration in 2019, bringing the total number cleared by the agency up to 26.

Seven more of that group launched commercially, offering doctors the option to prescribe a lower-cost alternative to branded biologic medicines.

For a market that's widely fallen short of expectations since approval of the first U.S. biosimilar in 2015, the past 12 months suggest a hastening maturation. Multiple competitors now exist for four different biologic drugs — a state of affairs that the industry's experience with generic drugs indicates is necessary for bringing down prices.

But this year has also seen spirited debate between experts and former government officials over whether the biosimilar experiment is even worth the effort.

Certainly, the discounts to date are modest. Most biosimilars list for a price between 15% and 35% of what the branded version costs — sizable yet far from the 80% savings generics often bring.

Many of the top-selling drugs in the U.S. are biologics, however, and even a moderate discount on tens of billions of dollars in drug spending could be substantial.

Translating that savings potential into reality has been the sticking point. Patent litigation has kept half of the approved biosimilars from consumers, while regulatory standards mean pharmacists can't yet substitute biosimilars for prescribed biologics, as they can with generics.

If more launch and the Food and Drug Administration begins granting interchangeable status, the market for biosimilars could be meaningful for healthcare budgets.

Ned Pagliarulo Senior Editor

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