FDAnews Announces — Biosimilars on the Rise: The Latest on FDA’s Guidelines and Guidances Webinar, June 3, 2020

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The biosimilar product market is opening up with a wave of expiring regulatory exclusivities. Successfully navigate the FDA approval process…

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WCG FDAnews

Biosimilars on the Rise:
The Latest on FDA’s Guidelines and Guidances
An FDAnews Webinar
Wednesday, June 3, 2020 • 1:30 p.m. – 3:00 p.m. EDT
https://www.fdanews.com/biosimilars

The pharmaceutical industry is entering a new wave of expiring regulatory exclusivities regarding biologics, opening up opportunities for manufacturers. Want to be sure the team doesn’t miss out on this chance for increased market involvement?

Nicholas Mitrokostas, a partner with Goodwin Procter, will share how the FDA is managing new biosimilar product applications and how one can best navigate the complex process of developing FDA-approved biosimilar products:

  • The current state of biosimilar approvals by the FDA

a. Developing biosimilar products and earning FDA approval

  • Recent FDA draft guidances impacting biosimilars and biologics

a. The deemed to be a license provision
b. Demonstrating interchangeability with a reference product
c. Clinical immunogenicity considerations for biosimilar and interchangeable insulin products
d. Promotions, labeling, and advertising of biologic and biosimilar products
e. Approval of biosimilars for fewer than all approved indications

The current biosimilars space is nearing a time of immense growth and potential. Discover how to earn FDA approval and take advantage of these opportunities.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Biosimilars on the Rise:
The Latest on FDA’s Guidelines and Guidances
An FDAnews Webinar
Wednesday, June 3, 2020 • 1:30 p.m. – 3:00 p.m. EDT
https://www.fdanews.com/biosimilars

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/biosimilars
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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