The annual Food & Drug Law (FDLI) conference will be held on June 14-15, bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia to address complex legal, regulatory, compliance, and policy issues facing the FDA-regulated industry. Goodwin is a proud sponsor of the conference and partner Brian Burgess is a featured speaker on the panel, Interchangeable Biosimilars – Emerging Legal Issues and Trends. During this session, the speakers will discuss what can be learned from the first interchangeable approvals and what it tells us about FDA’s interchangeability framework. The speakers will also address what the competitive landscape for biologics looks like, how the statutory standard regarding “any given patient” may play out, and whether applicants will be able to use real world evidence to support interchangeable licensure.
Blog Life Sciences Perspectives May 23, 2022