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Court Denies TRO/PI in Genentech v. Amgen; Amgen Announces Launch

As we previously reported, on July 10, 2019, Genentech filed  motions for a temporary restraining order and preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI™ (trastuzumab-anns).  Yesterday, the District Court denied Genentech’s motions and lifted the standstill order given during the…

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Judge Vacates Federal Regulation Mandating Disclosure of Drug Prices in TV Advertisements

In May, the U.S. Department of Health and Human Services (“HHS”) finalized a new regulation requiring pharmaceutical companies to disclose the list price of a drug in any television advertisements.  This regulation, titled “Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency” (also known as the Wholesale Acquisition Cost,…

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Genentech Moves for Temporary Restraining Order and Preliminary Injunction Against Amgen

Last night, Genentech filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI (trastuzumab-anns).  Genentech’s motion papers were filed under seal, and Amgen’s responsive papers on the preliminary injunction motion…

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Biosimilar and Follow-On Biologic Development Updates

Below are some highlights of recent news in biosimilar and follow-on biologic development: Prestige BioPharma On July 2, Prestige BioPharma (Prestige) licensed the rights to Tuznue, its trastuzumab biosimilar of Roche’s Herceptin, to Mundipharma in selected European markets. The European Medicines Agency (EMA) recently accepted a Marketing Authorisation Application for…

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Samsung Bioepis and Genentech Settle Trastuzumab Biosimilar Patent Disputes

On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year.  According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss…

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AbbVie to Acquire Allergan for $63B

U.S.-based AbbVie, Inc. has reached a deal to acquire Irish pharmaceutical company Allergan PLC for about $63 billion, according to an AbbVie press release from Tuesday.  The “definitive transaction agreement” includes both cash and stock.  According to the press release, it is expected that, immediately after the closing of the…

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