A Biosimilar by Any Other Name - Webinar CD/Transcript

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A Biosimilar by Any Other Name: What the FDA’s Draft Rules Mean for You

It’s been a long time coming.

In August, the FDA published it’s highly anticipated draft guidance on naming biosimilars. Massive controversy has erupted over whether biosimilars need to be named differently from their originals, and if so, how.

What do doctors and patients need to know, and what will just confuse them? The WHO and the EMA have their own alternative naming schemes under consideration. China, Australia and Mexico are weighing in as well.

Kevin Nelson, an expert in pharmaceutical intellectual property law, explains:

  • The genesis of the issue: how small molecule products are named and why
  • The arguments and policy concerns on both sides of the naming dispute prior to the FDA’s guidance
  • Deep dive into the FDA’s guidance: what questions were answered and what questions remain
  • Naming in practice: Sandoz’s Zarxio, a.k.a. filgrastim-sndz — why the FDA needed to implement a naming guidance now
  • Putting the cart before the horse: what about interchangeability?

Get the whole story on biosimilars today, and be ready for this new field as it develops.

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Kevin Nelson, Partner, Duane Morris LLP
Kevin M. Nelson practices in the area of intellectual property with a focus on complex pharmaceutical patent litigation. For the past 12 years, Mr. Nelson has represented generic drug companies in patent litigation brought under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. He has also represented clients before the U.S. Food and Drug Administration in regulatory matters and in opposing citizen petitions. In addition, Mr. Nelson has advised clients regarding biosimilars applications and litigation.