The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee for Medicinal Products for Human Use (CHMP) had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved…
On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year. According to Amgen Executive Vice President and CFO David Meline, Amgen is operating under the assumption of “biosimilar competition against Neulasta…
Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front: Pfizer recently reported in a press release announcing financial results for Q4 2016 that in December 2016 its subsidiary Hospira resubmitted its aBLA for Retacrit,…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, directed to monoclonal antibodies including infliximab or cA2 antibody, is invalid. On January 26, 2017, pursuant to a 30-day extension, Janssen filed its opening appeal brief, in which Janssen challenged the two district…
Yesterday, Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents are directed to methods of treating certain cancers with trastuzumab, sold under the name Herceptin®. These petitions follow closely on the heels of three…
Today, Coherus Biosciences filed four petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619 (IPR2017-00822, IPR2017-00823, IPR2017-00826, and IPR2017-00827). According to the petitions, the patent is drawn to formulations of adalimumab, commercially available under the brand-name Humira®. Coherus already has three instituted IPR proceedings on patents related to adalimumab, IPR2016-00172, IPR2016-00188,…
As we previously reported, Bristol-Myers Squibb Co. and Ono Pharmaceutical Company sued Merck & Co. in 2015 alleging that Merck’s sale of Keytruda® infringes a patent directed to the use of anti-PD-1 antibody to treat metastatic melanoma. Last week, the parties announced that they settled the litigation. According to the…
Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending approval for all available indications.” Amgen’s biosimilar adalumimab was approved in the United States on September 23, 2016. The CHMP’s…
Yesterday, during its Q4 2016 earnings call, Novartis CMO Vasant Narasimhan told investors that its subsidiary Sandoz had delayed filing its aBLA for a biosimilar of Humira® (adalimumab), which originally had been planned for Q4 2016. According to Mr. Narasimhan, Sandoz has “pushed [the filing] into the first half of…
The Supreme Court has ordered a briefing schedule in Amgen v. Sandoz. Because the Court granted and consolidated Sandoz’s petition and Amgen’s conditional cross-petition, the Court has adopted a four-brief schedule, comparable to the procedure used in the courts of appeals. According to the order, the briefing schedule will be as…