Biologic drugs — used to treat diseases such as rheumatoid arthritis and cancer — accounted for 70 percent of the growth in U.S. prescription drug spending from 2010 to 2015. Policymakers in Washington, including the FDA’s Scott Gottlieb, are pushing biosimilars as a way to introduce competition into the biologics market and restrain their price increases — and have recently released a slate of policies intended to reinvigorate the market.

But the experience so far raises questions about the effectiveness of this strategy: Many biosimilars approved by the FDA have not made it onto the U.S. market, even as they’re being sold in Europe, while other biosimilars have been approved by European regulators but not by the FDA. STAT senior writer and Pharmalot columnist Ed Silverman and STAT Washington correspondent Nick Florko discussed why.

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