On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA...more
On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection. ...more
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
On April 14, 2025, Celltrion announced that the FDA designated Yuflyma® (adalimumab-aaty) as an interchangeable biosimilar of AbbVie’s Humira® (adalimumab). Yuflyma® is a high-concentration (100mg/mL) citrate-free...more
On April 14, 2025, Celltrion, Inc. announced that the U.S. Food and Drug Administration granted an interchangeable designation to YUFLYMA (adalimumab-aaty), its biosimilar referencing HUMIRA (adalimumab). ...more
On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more
On March 7, 2025, the FDA approved Celltrion’s Omlyclo® (omalizumab-igec), the first interchangeable biosimilar of Genentech’s Xolair® (omalizumab). Omlyclo® was approved for all of Xolair®’s approved indications, including...more
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more
On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement...more
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first...more