FDA to Hold Public Hearing on Biosimilar Action Plan

In order to gather stakeholder input on the initiatives explained in the Biosimilar Action Plan unveiled by FDA Commissioner Scott Gottlieb, MD, last week, the FDA has announced that it will hold a public hearing on the plan on September 4, 2018.

The action plan addressed 4 key areas intended to improve biosimilar competition:

• Improving the efficiency of the biosimilar and interchangeable product development and approval process
• Maximizing scientific and regulatory clarity for the biosimilar product development community
• Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
• Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products

The “FDA is soliciting input from the public on how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation that Congress intended to achieve under the [Biologics Price Competition and Innovation Act],” according to the agency’s announcement. In particular, the FDA is interested in how it can leverage its existing statutory authority to regulate biologics and biosimilars to address issues around the current lack of competition in the market.

Within the announcement, the FDA listed specific questions on which it would like to receive stakeholder feedback, including how the agency can help biosimilars reach patients more quickly after approval, what additional information should be included in the Purple Book to make it more useful, what new steps the agency can take to facilitate evolution of the biologics and biosimilars marketplace, what the agency can do to help reduce development costs without sacrificing safety and quality of biosimilars, how the agency can facilitate multinational development programs that may include reference products licensed outside the United States, and how the FDA can ensure that changes to biologics do not inappropriately deter biosimilar competition.

Electronic comments may be submitted to the Federal Register until September 21, 2018.