Is Biosimilars Regulation Taking a Major Turn?: The Latest Must-Know Developments, Including BsUFA III – Webinar Recording/Transcript
You’re determined to move your biosimilars ahead but the pace can be slow. With the FDA approving fewer than 30 in the decade-plus the pathway opened, the way forward is challenging at best.
But the FDA’s recent and forthcoming guidelines and guidances hold keys to moving your biosimilars and biologics ahead — from development through approvals.
Nicholas Mitrokostas, a partner in Goodwin Procter, LLP’s Boston office and an editor of the recent Guide to Biosimilars Litigation and Regulation in the U.S., will explain what you must know about the state of the FDA’s guidance and how to use it to facilitate biosimilars development and approvals.
He’ll take you through seeking approval for fewer than all approved indications of the reference product, considerations for developing and seeking approval for interchangeable biosimilars and recent developments relating to the Biosimilars User Fee Act III (BsUFA III).
- Understand the current state of approvals
- Gain clarity on recent FDA guidances impacting biosimilars and biologics, including:
- Draft guidance for Considerations in Demonstrating Interchangeability with a Reference Product
- Draft guidance for Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed
- BsUFA III (with BsUFA II expiring in September 2022)
This is the ideal time to move your biosimilars forward. Start here to do just that.
Meet Your Presenter
Nicholas Mitrokostas, a partner in Goodwin Procter, LLP’s Boston office, is an experienced litigator in the Life Sciences space. For nearly 20 years, he has counseled and represented companies developing pharmaceutical products on intellectual property and regulatory issues. Mr. Mitrokostas is the editor-in-chief of Goodwin’s blog on biologics and biosimilar legal, regulatory and market developments, www.bigmoleculewatch.com. In addition, he is an editor of Guide to Biosimilars Litigation and Regulation in the U.S., which was recently published by Thomson West.
Who Will Benefit
Individuals working on the development and approval of biosimilars:
- R&D personnel
- Manufacturing professionals
- Regulatory personnel
- In-house counsel evaluating risks and opportunities
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Aug. 10, 2021