Blog Big Molecule Watch February 25, 2019

Discussion: Biosimilars Litigation & Regulation in the EU/UK and U.S.

We are excited to share a series of videos produced in collaboration with Bristows LLP focused on the areas of biosimilars litigation and regulation in the U.S. and EU/UK.  Stay tuned over the next several weeks as we release new videos!

The series will cover these topics:

•  Overview of Differences Between Governing Schemes for Biosimilars
•  Differences Between Regulatory Requirements for Biosimilar Approval
•  Differences Between Patent Infringement Litigation and Invalidity/Revocation Proceedings
•  Opposition and IPR Proceedings In Patent Offices
•  Antitrust and Settlement Regulations Pertaining to Biosimilars

In the first video, Overview of Differences Between Governing Schemes for Biosimilars, Dom Adair, Partner at Bristows and Rob Cerwinski, Partner at Goodwin provide an overview of EU/UK and U.S. statutory and regulatory schemes.

Click here for the video which covers:

•  Marketing and data exclusivities
•  Standards for biosimilarity
•  Interchangeability and substitution
•  Patent litigation resolution schemes
•  Patent office vs. court proceedings

Stay tuned for the next video and additional updates!

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