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  1. News & Events for Human Drugs

2017 PDA/FDA Biosimilars Conference, June 26-27, 2017

Location:

Hyatt Regency Bethesda
1 Bethesda Metro Center
Bethesda, MD 20814
https://bethesda.regency.hyatt.com/en/hotel/home.html disclaimer icon

Background:

The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval for biosimilars, including:

  • Risk-based approaches to setting product specifications for quality attributes.
  • Practical solutions for establishing suitable control strategies over the biosimilar product lifecycle.
  • Approaches for global post-marketing change control.
  • Expectations for demonstrating analytical similarity.

Goals and Objectives:

  • Provide a forum for open discussion between industry, academia, regulatory agencies, and other stakeholders.
  • Seek feedback on best practices for risk-based approaches to setting product specifications for tier 1 and 2 quality attributes.
  • Map out priorities for control strategies over the biosimilar product lifecycle.
  • Accelerate the development and review of biosimilars.
  • Ensure that leading experts in biological products and biosimilars have an opportunity to discuss current Agency expectations for approval for biosimilars.

Who should attend?

This conference is intended for a diverse group including:

  • Scientists, clinicians, regulatory, and quality personnel, responsible for the evaluation of safety and efficacy of biosimilars;
  • Parties interested in ongoing efforts on research and development of biosimilars;
  • Program officers from agencies such as FDA, NIH, and CMS and their global counterparts.

Register:

To register to attend this event, visit the event registration page: PDA/FDA Biosimilars Conferencedisclaimer icon

Contact:

Andrea Chamblee at Andrea.chamblee@fda.hhs.gov