Biologics and Biosimilars: Development with an Eye Towards FDA Approval

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final guidance on nonproprietary naming of biological products. The interchangeability guidance provided more insight into the evidence required to meet the standard for an interchangeability rating, including the scientific justification for extrapolation from one condition of use to another, the recommended framework for switching studies between the reference product and the proposed interchangeable product, and the considerations for determining when post-marketing data is needed. With billions of dollars at stake, how do the new guidelines affect approved and soon-to-be reviewed biosimilar products? What are the best practices for interfacing with the FDA prior to and during the approval process? How might the Trump administration’s policies impact the FDA approval process for biologics, biosimilars, and interchangeables? 

The second program of this webinar series expands upon issues impacting biologics and biosimilar development, including FDA regulatory issues and interfacing with the FDA before any applications are filed, decisions concerning the types of evidence that are likely to be required to obtain FDA approval, and the FDA’s guidance on naming and labeling of biosimilar products. 

• Considerations in selecting a biologic or biosimilar for development
• Pre-filing meetings with the FDA, including participation in the Biosimilar Development Program
• Types of evidence to establish biosimilarity
• Types of evidence to establish interchangeability
• Naming and labeling requirements

Moderator: 
Basil “Bill” J. Lewris

Speakers: 

Alissa K. Lipton
Linda A. Wadler

Date:

Friday, February 17, 2017

Time:

10:00 - 11:00 a.m. PST
1:00 - 2:00 p.m. EST

Scheduling Conflict? Finnegan records all hosted webinars. To view the recorded program, simply register for the webinar and you will receive an access link shortly after the live program is complete.