Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018: 1. 2018 Sets New Records for Biosimilar Approvals and Launches When 2018 began, nine…
Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018: 1. 2018 Sets New Records for Biosimilar Approvals and Launches When 2018 began, nine…
Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars. Bevacizumab: China-based Innovent Biologics announced last week that IBI305, a…
In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for…
As we have reported, over the course of the past thirteen months Plaintiffs Genentech, Inc. and City of Hope sued each of Pfizer, Celltrion and Teva, Amgen and Samsung Bioepis…
Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have…
Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab. According to the…
AbbVie filed its opening claim construction brief in its litigation with Boehringer Ingelheim (BI). AbbVie asserted eight patents against BI. The parties narrowed their dispute to two claim terms in…
As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar…
Following the FDA’s approval of Retacrit® (epotein alfa-epbx) as the first U.S. biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® this past May, today Pfizer announced that…
Below is a summary of recent updates in biosimilar-related proceedings before the Patent Trial and Appeal Board of the United States Patent and Trademark Office. Trastuzumab: Last month, the…