On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the…
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together, “Genentech”) and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co….
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 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…
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…
On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694. Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for their preparation and use. The patent does not focus on any particular therapy, but Genentech notes that the approach was used to develop Herceptin®,…