Rosen Comments on FDA Plan to Facilitate Biosimilars

25 July 2018 Regulatory Focus News
Partner David Rosen was quoted in an article in Regulatory Focus, “FDA Plans Hearing on Biosimilar Competition, Development,” about the U.S. Food and Drug Administration’s plan to hold a public hearing to gather input on how it can facilitate the development of biosimilars and help bring them to market in a timely fashion.

Rosen said the legal issues delaying the launch of biosimilars are outside the FDA’s purview. “That’s in the hands of the courts and the companies that are involved,” he said.

He also said that the FDA could have a greater impact on competition by facilitating the development of more biosimilars, which in turn could lead to lower prices for products with multiple biosimilar competitors.

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