FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Biosimilar Groups Seek ‘Structural’ Changes in U.S. Market

March 29, 2019
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Biosimilar groups are pressing federal agencies including the FDA to make “structural” changes to the biosimilar marketplace, claiming that the U.S. is falling far behind Europe on cheaper treatments.

Europeans have moved ahead by cutting down on red tape and aggressively using biosimilars in their health spending, say the Biosimilars Forum in Washington, D.C., and Medicines for Europe in Brussels, Belgium, in a joint report released this week.

Europeans now make up 90 percent of world biosimilar sales, a gap that reflects the failure of biosimilar uptake in the U.S. market but also the “increasing opportunities for biosimilars to offer savings in the U.S.,” the groups claim.

Among more than a dozen specific recommendations, the groups urge U.S. payers to actively encourage biosimilars by giving them priority tiering in formularies along with reduced or zero-dollar co-pays for patients.

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