Search Results: test BPCIA and Related U.S. Statutes

Janssen v. Celltrion: Motions to Exclude or Limit Evidence and Testimony from the Upcoming Trial

With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…

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Regulators Highlight Differing International Biosimilar Regulations; Interchangeability Guidance May Slip to 2017

Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their biosimilar guidances. For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways…

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Will Trump's Election Impact the BPCIA?

The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although we are not aware of President-elect Trump ever directly mentioning biosimilars on the campaign trail, it is…

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