On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen’s PROLIA and XGEVA, respectively. As…
On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen’s PROLIA and XGEVA, respectively. As…
On January 12, 2026, AbbVie and RemeGen announced an exclusive licensing agreement granting AbbVie rights to develop, manufacture, and commercialize RemeGen’s RC148 outside of Greater China. In…
This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on…
On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™ (denosumab-mobz), biosimilars…
On December 11, 2025, Regeneron filed a Memorandum in Support of Its Motion to Bifurcate and Stay Amgen’s Antitrust Claims in the ongoing aflibercept patent litigation in the U.S. District…
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. On December…
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled…
On November 24, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. and Amgen…
On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is…
On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem…