Authors

Matthew Royle, Ph.D.

Partner

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Judith Krens

Partner

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Dr. Manja Epping

Partner

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Evelyne Friedel

Partner

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Authors

Matthew Royle, Ph.D.

Partner

Read More

Judith Krens

Partner

Read More

Dr. Manja Epping

Partner

Read More

Evelyne Friedel

Partner

Read More

22 September 2019 |

Biosimilars - clearing the way for launch

Many of the top-selling drugs worldwide are biologics, and several companies are seeking to produce biosimilars to compete in these lucrative markets. There are an increasing number of biologics reaching the end of the primary patent protection and these companies must navigate the landscape of secondary patent protection in order to launch their biosimilars. The strategies for doing so differ in the US and Europe and there are different tools available.

In this third session we focus on strategic options for securing an early launch of a biosimilar. In particular:

  • devising a strategy to clear the way in Europe
  • do-called Arrow declarations may be available to provide a defence to any pending patent applications
    • in the Netherlands, a recent case has clarified the court's jurisdiction to consider Arrow relief
    • in the UK, a recent case has clarified the circumstances in which an Arrow declaration will be granted
  • devising a strategy to clear the way in the US.

View session 1

View session 2


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