FDA/FTC Joint Workshop on a Competitive Marketplace for Biosimilars – Comments from Stakeholders

As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.”

On March 9th, the two agencies held a public workshop to discuss their “collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace.”

The workshop drew a number of comments from various stakeholders representing health insurance companies, healthcare group purchasing organizations, manufacturers and suppliers of biosimilar products and materials, policy groups, pharmacy benefit managers, and others.  A total of 28 comments were submitted on the public docket.  Those comments, along with slides from the workshop, are available here: https://www.regulations.gov/docket?D=FDA-2019-N-6050.

Download PDF