Search Results: test Approved Biosimilar Products

Boehringer Ingelheim's First Biosimilar Is Approved in Europe

Boehringer Ingelheim (BI) announced today that it received marketing authorization in Europe for Cyltezo®, which is a biosimilar to Humira®.  Cyltezo® was approved for the treatment of multiple chronic inflammatory diseases in adults and children.  As previously reported, BI’s Cyltezo® was approved by the FDA on August 25, 2017, and…

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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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Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid.  Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…

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Litigation Update: Case Management Statement in Amgen v. Sandoz (filgrastim, pegfilgrastim)

The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio® (filgrsatim-sndz), which Sandoz launched in September, 2015) and Case No. 3:16-cv-02581-RS (accused product: pegfilgrastim (biosimilar to Amgen’s Neulasta®). The parties…

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