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.

Related Services

Insights

Should This Be a "Mobility" Industry Blog?
19 November 2019
Dashboard Insights
Will Other Tech Companies Join Microsoft in Honoring CCPA Across the U.S.?
18 November 2019
Internet, IT & e-Discovery Blog
Get Off My Lawn! Employers Gain Expanded Rights to Keep Unions Away from Their Property
18 November 2019
Labor & Employment Law Perspectives
Debunking Conventional Labor and Employment Wisdom
18 November 2019
Labor & Employment Law Perspectives
PATH Summit 2019
18-20 December 2019
Arlington, VA
Madison CLE Days
18-19 December 2019
Madison, WI
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call