Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. These indications are the same as those for which the reference product is approved. Trazimera™ is the fourth trastuzumab biosimilar, and the…
As we previously reported, in October 2018, Genentech brought claims against Taiwan-based biosimilar developer JHL Biotech, Inc. and individual defendants for trade secret misappropriation, computer fraud, breach of contract, and other claims. The alleged trade secrets relate to several of Genentech’s products: Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme®…
On February 28, 2019, the FDA approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk). According to a press release from Roche, Genentech’s parent company: “This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under…
Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development. According RAPs, Pfizer’s Director of Global Media Relations, Thomas Biegi, said that resources from these programs would be reallocated “to late stage programs across Pfizer’s other key…
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…
On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®. Prestige’s HD201 is in Phase-3 clinical development for the treatment of patients with HER2-overexpressing breast cancer. According to the press release, under the agreement, Cipla will…
Today, the FDA approved Celltrion’s Herzuma (trastuzumab-pkrb), a biosimilar that references Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer, in accordance with the FDA-approved label. Celltrion’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This marks the seventh biosimilar the FDA has approved…
As we have reported, over the course of the past thirteen months Plaintiffs Genentech, Inc. and City of Hope sued each of Pfizer, Celltrion and Teva, Amgen and Samsung Bioepis in the District of Delaware for patent infringement under the BPCIA based on their submissions of aBLAs seeking FDA approval…
Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have already reported: Today, December 3, 2018, Celltrion announced that the European Medicines Agency (EMA) has accepted Celltrion’s Extension Marketing Authorisation Application for…
Below is a summary of recent updates in biosimilar-related proceedings before the Patent Trial and Appeal Board of the United States Patent and Trademark Office. Trastuzumab: Last month, the Board issued two Final Written Decisions in IPRs of U.S. Patent No. 7,892,549, which is directed to methods for the treatment…