On January 30, 2019, Allergan and its partner Medytox filed a complaint with the ITC to block imports of Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection) product, DWP-450, manufactured by Daewoong Pharmaceuticals. The complaint alleges that Daewoong misappropriated trade secrets of Medytox. Evolus filed a BLA for DWP-450 and it was accepted…
The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space. The report notes that, by monitoring the pharmaceutical market to ensure that price competition for pharmaceuticals is not artificially reduced or eliminated, and…
On January 22, 2019, the Supreme Court issued its decision in Helsinn Healthcare v. Teva Pharmaceuticals USA, holding that under § 102(a), as amended by the American Invents Act (“AIA”), an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential could still…
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…
Earlier this week, Bio-Thera Solutions announced the initiation of the Phase III clinical study for its tocilizumab biosimilar, BAT1806. According to the press release, the Phase III clinical study will enroll over 65 patients at more than 45 sites around the world, and will compare the safety and efficacy of…
On Jan. 14, Rep. Elijah E. Cummings, the Chairman of the Committee on Oversight and Reform, issued a press release that his office had sent letters to 12 drug companies seeking “detailed information and documents about the companies’ pricing practices,” including material regarding price increases, investments in research and development,…
Last October, we reported that Taiwan-based Tanvex BioPharma (“Tanvex”) announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for chemotherapy induced neutropenia. Last November, the FDA accepted Tanvex’s BLA for its filgrastim biosimilar. This week Tanvex has submitted a New Drug Submission (NDS) to…
Alvotech announced today that its current product pipeline of “six biosimilar monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases” will receive an injection of capital from funds raised through a private bond offering. Having raised US$300 million, Alvotech plan to use the net proceeds “to fuel continued…
Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This is the third biosimilar…