There will soon be a new director of Therapeutic Biologics & Biosimilars Staff (TBBS) in the Office of New Drugs (OND) at the FDA. Dr. Sarah Yim will become the new acting director of TBBS beginning in March. Dr. Yim joined the FDA in 2005 and is currently the director…
On Monday, a Delaware federal jury awarded $155 million to Bayer for infringement of U.S. Patent No. 9,364,520, which covers several of Bayer’s hemophilia medications, including Kogenate, Kogenate FS, and Kovaltry. The ‘520 patent claims full-length Factor VIII that is pegylated at its B-domain site and compositions thereof. The verdict was entered…
This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR challenge. The Court dismissed Momenta’s appeal “for absence of standing/jurisdiction and for mootness.” As we have previously reported, although the Federal…
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,…