Tagged as: Humira

7th Circuit Evaluates the "Patent Thicket"

Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402.  The appeal concerns the United States District Court for the Northern District of Illinois’ dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket”…

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Celltrion begins Phase 3 trial of aflibercept biosimilar

Celltrion Inc. has begun a Phase 3 clinical trial of CT-P42, an aflibercept biosimilar referencing Regeneron’s Eylea.  The trial will enroll 300 patients with diabetic macular edema, and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea. Celltrion adds CT-P42 to its pipeline of other investigational biosimilars, including…

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Vizient Looks to Biosimilars to Help Contain COVID-19 Drug Price Inflation

Last week, Vizient, a healthcare performance improvement company, released its Summer 2020 Drug Price Forecast.  In the forecast, Vizient reported on the role of COVID-19 in changing healthcare priorities and affecting spending.  Particularly, it advised its member health care groups to hedge against drug price inflation, which it estimated will…

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Biologic and Biosimilar Approval Updates

The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…

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Abbvie and Adalimumab Biosimilar Manufacturers Face Class-Action Lawsuit Alleging Antitrust Violations Related to Patent Protection of Humira®

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….

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AbbVie Grants Momenta Global Patent Licenses for Biosimilar of HUMIRA (Adalimumab)

Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab).  According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States…

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Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October.  On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets.  This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.  According to…

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