On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States….
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar. According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…
On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current thinking on biological products licensed under Section 351 of the Public Health Service Act (“PHS Act”). This draft guidance serves…
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 March 4, 2019, Eli Lilly announced that they will begin selling a lower-priced version of Humalog® (isulin lispro injection 100 units/mL) in the United States with a list price 50% lower than the current Humalog® list price. The lower-priced version will be called Insulin Lispro and will be provided in…
Dr. Scott Gottlieb, who has served as FDA Commissioner since May 2017, has announced that he will be resigning from the agency. Dr. Gottlieb has previously voiced support for wider access to biosimilars.
On March 1, 2019, Novartis sued Johnson & Johnson subsidiary Janssen for allegedly presenting false and misleading data about its plaque psoriasis drug Tremfya® (guselkumab). Novartis alleges that its Cosentyx® (secukinumab) drug, which is also indicated for the treatment of plaque psoriasis, competes with Tremfya®. Novartis claims that Janssen failed to…
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…
We are excited to share a video produced in collaboration with Bristows LLP focused on the areas of biosimilars litigation and regulation in the U.S. and EU/UK. In this video , Overview of Differences Between Governing Schemes for Biosimilars, Dom Adair, Partner at Bristows and Rob Cerwinski, Partner at Goodwin…