Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey,…
Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey,…
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as…
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v….
It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to…
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a…
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon…
Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United…
Our readers may recall that ten HUMIRA biosimilars have been licensed to launch, with Amgen’s AMJEVITA the only one to launch to date and nine others set to launch starting…
The 14th Annual American Conference Institute’s (ACI) Summit on Biosimilars & Innovator Biologics will be held on June 27-28, bringing together the “who’s who” of the biosimilars…
Alvotech and Teva Pharmaceuticals, Inc. announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to…