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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 webinar 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.
Our Presenter will share how you and your team can best navigate the complex process of developing FDA-approved biosimilar products.
During this webinar, we will cover:
• The current state of biosimilar approvals by the FDA
o Developing biosimilar products and earning FDA approval
• Recent FDA draft guidances impacting biosimilars and biologics, including:
o The deemed to be a license provision
o Demonstrating interchangeability with a reference product
o Clinical immunogenicity considerations for biosimilar and interchangeable insulin products
o Promotions, labeling, and advertising of biologic and biosimilar products
o 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. Join us by registering today.
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