作者

Dr. Manja Epping

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Evelyne Friedel

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Matthew Royle, Ph.D.

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作者

Dr. Manja Epping

合伙人

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Evelyne Friedel

合伙人

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Matthew Royle, Ph.D.

合伙人

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0001年1月1日 | 48:40

Biosimilars - an overview of the route to market in the US and Europe

Many of the top selling drugs worldwide are biologics and many companies are seeking to produce biosimilars to compete in these lucrative markets. Activity relating to biosimilars is intensifying in the US following the introduction of the BPCIA and continues in Europe since the first biosimilars were authorised in 2006. Successfully bringing a biosimilar to market raises different challenges to small molecule generics and there are differences in the approach in the US and Europe.

Taylor Wessing and Willkie Farr & Gallagher are hosting a series of three webinars covering various aspects of market access for biosimilars.

In this first webinar 'Biosimilars - an overview of the route to market in the US and Europe' we discussed:

  • Basics of the regulatory system in the US and Europe
  • History of approvals and launches in the US and Europe
  • Overview of the "patent dance" under the BPCIA and contrast to the position in Europe
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