The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech. According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…
AbbVie filed its opening claim construction brief in its litigation with Boehringer Ingelheim (BI). AbbVie asserted eight patents against BI. The parties narrowed their dispute to two claim terms in three patents. U.S. Patent Nos. 9,018,361 (“’361 patent”) and 9,090,867 (“’867 patent”) are directed to methods of manufacture of adalimumab. U.S….
As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion argued that under the claims of the patent, the salts and protein used to produce pegfilgrastim must be…
As we previously reported, Biogen has exercised its option to purchase additional shares of Samsung Bioepis, increasing Biogen’s ownership in the Samsung Bioepis joint venture from approximately 5.4% to approximately 49.9%. Last week, Samsung BioLogics announced that the asset transfer deal closed, transferring 9,226,068 shares of Samsung Bioepis to Biogen…
Following the FDA’s approval of Retacrit® (epotein alfa-epbx) as the first U.S. biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® this past May, today Pfizer announced that it has launched Retacrit® in the United States. According to reports, Pfizer began shipping Retacrit® to wholesalers on November 12, 2018, at…
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…
On October 25, 2018, the U.S. Attorney for the Northern District of California filed an indictment against four individuals (three of whom were former Genentech employees) alleging theft of trade secrets, computer fraud and abuse, and other crimes. The indictment alleges that the defendants stole trade secrets related to Genentech’s products…
On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv) biosimilar product. President, CEO and Chairman Denny Lefler told financial analysts on the call that Udenyca™ will be available for…
As we previously reported, Amgen is appealing the District Court’s decision to dismiss, with prejudice, Amgen’s patent infringement complaint against Coherus regarding its (recently approved) biosimilar of Neulasta® (pegfilgrastim). Amgen filed its opening brief on August 20, challenging the district court’s dismissal of the suit. On October 31, 2018, Coherus filed…
On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an aBLA relating to Truxima®, Celltrion’s proposed biosimilar to Rituxan® (rituximab), infringed certain patents. The…