The Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), announced a public workshop on a competitive marketplace for biosimilars and opportunity for public comment. The purpose of the meeting is to discuss the FDA and FTC’s collaborative efforts to support the adoption of biosimilars, discourage false or misleading communication about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.
The workshop will focus on the following topics:
- U.S. biosimilar markets and FDA approval process;
- Enforcement activities by FDA and FTC;
- The benefits of competition; and
- Improving stakeholder engagement: education and access.
The FDA is also seeking comments from stakeholders and the public related to steps the FDA and FTC can take to facilitate a competitive market for biological products.
The meeting will take place on March 9 and public comments will be accepted until April 9. More information on registration can be found here.