FDAnews Announces: Biosimilars Regulation, Law & Policy: At a Crossroads?, Sept. 28, 2017

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The biosimilars revolution is at a crossroads. FDAnews has convened the stars of biosimilar law and policy, as well as industry leaders, for a one-day mini-summit to set manufacturers on the path to success.

The biosimilars revolution is at a crossroads.

Will the FDA’s new interchangeability guidance turn out to be a roadmap or merely a starting point? Will the Gottlieb FDA prove friend or foe? How will courts respond in the wake of Sandoz. v. Amgen?

Come to Washington Thursday, Sept. 28 and get answers.

FDAnews has convened the stars of biosimilar law and policy, as well as industry leaders, for a one-day mini-summit to set manufacturers on the path to success. Attendees will dive deep into the FDA’s new guidance and sort out the nuances of interchangeability, pharmacovigilance, patents, marketplace issues and more:

  • Which is the better approach: To strive for the higher standards set forth in the FDA’s interchangeability guidance? Or settle for “highly similar”
  • Sandoz v. Amgen: How does the Supreme Court ruling affect manufacturers?
  • Global impact of product naming on pharmacovigilance
  • Local impact of state pharmacy laws
  • The patent dance: A rundown on current issues, plus best ways to leverage uncertainty with patent applications
  • Prescribing and pricing of biosimilar product approvals in the U.S. and abroad
  • Leveraging one country’s biosimilar product approval in a second country, and pitfalls to avoid
  • AdComms’ announcement for proposed Amgen biosimilars: How it could affect biosimilars development
  • Regulatory and patent uncertainty: The effect on growth of a competitive biosimilars market
  • And much more!

Conference co-leaders Brian Malkin Esq. and George O’Brien Esq. are luminaries of the biosimilars bar. Keynoter Christine Simmon Esq. is AAM’s chief of policy. The luncheon keynoter, Steven Kozlowski (invited), is Director, Office of Biotechnology Products, OPQ/CDER/FDA. An all-star cast of industry movers and shakers rounds out the day’s lineup.

It all takes place in the Washington offices of Arent Fox, one of the nation’s top FDA law shops. Attendees will mingle with speakers and fellow attendees in a relaxed and casual setting. There’ll be plenty of networking opportunities at lunch and during refreshment breaks, and afterward the opportunity to repair to nearby watering holes and five-star restaurants for still more strategizing and networking.

Biosimilars hold great promise, but the issues are many and complex. The big prizes will go to players who master the intricacies early on.

Who Will Benefit

  • Executive suite
  • Strategic planners
  • Regulatory affairs
  • QA/QR/QC
  • Manufacturing executives
  • R&D
  • Marketing/sales
  • Legal counsel

Conference Details:
Biosimilars Regulation, Law & Policy:
At a Crossroads?
**Presented by FDAnews**
Sept. 28, 2017, Washington, DC
http://www.fdanews.com/biosimilarsreglawpolicy

Tuition:
In-Person Briefing: $497
Livestreaming: $447

Easy Ways to Register:
Online: http://www.fdanews.com/biosimilarsreglawpolicy
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
+1 (703) 538-7665
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