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FDA's New Draft Biologic Naming Guidance

On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”).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 This draft guidance serves…

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FDA approves a fourth biosimilar of HERCEPTIN

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…

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Court Enters Preliminary Injunction Against JHL In Biosimilar Trade Secrets Case

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®…

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Lilly to Launch Lower-Priced Insulin Product

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…

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Novartis Sues Janssen Over Tremfya® False Advertising

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…

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FDA Approves New Trastuzumab Product

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…

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