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…
On February 2, 2025, Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA. This marks the first U.S. BLA acceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer. Pertuzumab is currently indicated by…
On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®. Tocilizumab is a monoclonal antibody that can act as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The FDA approved AVTOZMA® for subcutaneous injection or intravenous infusion for treatment of…
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech, and Regeneron have all filed BPCIA complaints (sometimes several) asserting 20 or more patents. Does this reflect a…
Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. As we previously reported, HERCESSI was approved earlier…
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products: Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius…