Product Details
Biosimilars on the Rise: The Latest on FDA’s Guidelines and Guidances
Want to attend the live webinar on June 3? Click here to register.
The pharmaceutical industry is entering a new wave of expiring regulatory exclusivities regarding biologics, opening up a breadth of opportunities for manufacturers.
Want to make sure your team doesn’t miss out on this chance for increased market involvement?
Through this comprehensive presentation on the FDA’s most recent guidelines and guidances you’ll find the answers you need to understand how the FDA is managing new biosimilar product applications and explore the ways in which the industry could add to your current pharmaceutical undertakings.
Nicholas Mitrokostas, a partner with Goodwin Procter, will share how you and your team can best navigate the complex process of developing FDA-approved biosimilar products.
During this presentation, we will cover:
- The current state of biosimilar approvals by the FDA
- Developing biosimilar products and earning FDA approval
- Recent FDA draft guidances impacting biosimilars and biologics, including:
- The deemed to be a license provision
- Demonstrating interchangeability with a reference product
- Clinical immunogenicity considerations for biosimilar and interchangeable insulin products
- Promotions, labeling, and advertising of biologic and biosimilar products
- Approval of biosimilars for fewer than all approved indications
The current biosimilars space is nearing a time of immense growth and potential. Discover how you and your team can earn FDA approval and take advantage of these opportunities.
Meet Your Presenter:
Nicholas Mitrokostas, a partner at Goodwin Procter’s Boston office, is an experienced life sciences litigator. For nearly 20 years, Mr. Mitrokostas has counseled and represented companies developing pharmaceutical products on intellectual property and regulatory issues. He is the editor-in-chief of Big Molecule Watch (www.bigmoleculewatch.com), Goodwin’s blog on biologics and biosimilar legal, regulatory, and market developments. In addition, Mr. Mitrokostas is an editor of the Guide to Biosimilars Litigation and Regulation in the U.S., recently published by Thomson West.
Who Will Benefit:
- Teams at pharmaceutical companies covering complex generics and biosimilars
- Biosimilar development and approval staff
- Research and development staff
- Manufacturing staff
- Regulatory functions staff
- In-house counsel evaluating biosimilar risks and opportunities