As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of…
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of…
In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1….
On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. AVZIZI is the fifth…
Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung…
…Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s…
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…