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 1, 2025: Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of…
On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech’s PERJETA® (pertuzumab). Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to the product, excluding certain countries in Asia, while EirGenix is responsible for development, manufacturing, and…
On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive FDA approval. Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. POHERDY…
On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN). Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN. According…
As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab). On October 16, 2025, Xbrane Biopharma AB announced that it has entered into a financing solution with Fenja Capital II A/S (Fenja) to proactively secure the…
On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc. (“Biogen”) to pay Genentech, Inc. (“Genentech”) $88,348,123 in unpaid royalties plus interest. The parties stipulated to $35,903,701 in interest on October 3. As we reported previously, in 2004, Genentech granted a non-exclusive…
On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in patients aged 2 years and older. CRS is a potentially life-threatening condition brought on by a so-called “cytokine storm”…
On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab). The FDA approved OMLYCLO® with an interchangeability designation based on positive phase III data demonstrating comparable efficacy and safety profile with XOLAIR® (omalizumab), which is co-promoted by Genentech and…
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings. It is well known that the…
On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®. Tocilizumab is a monoclonal antibody that acts as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The EC approved AVTOZMA® for all indications of the reference product, including moderate…