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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2019年3月29日 | 51:21

Biosimilars webinar series – Recent developments in biosimilars settlements, market landscape and antitrust scrutiny

Many of the top-selling drugs worldwide are biologics, and several companies are seeking to produce biosimilars to compete in these lucrative markets. Activity relating to biosimilars has intensified in the US since the introduction of the BPCIA in 2009 and in Europe since the first biosimilars were authorised in 2006.

Successfully bringing a biosimilar to market raises distinct challenges as compared to small molecule generics, and there are significant differences to understand between the approaches to US and European laws, regulations, and markets.

Successfully bringing a biosimilar to market raises distinct challenges as compared to small molecule generics, and there are significant differences to understand between the approaches to US and European laws, regulations, and markets.

This first in our series of 2019 webinars on the key differences between US and Europe biosimilars litigation and regulation focuses on key factors decision makers need to be aware of when considering settlement, including:

  • Recent biosimilars settlement agreements in the US and Europe.
  • Legal requirements driving settlement in Europe.
  • FTC scrutiny of biosimilars settlements in the US.
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