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Articles by Autumn Soucy
Celltrion and Genuv Partner to Develop Novel Therapeutic Antibodies | JD Supra
Celltrion and Genuv Inc., a Seoul-based a clinical-stage biotechnology company focused on drug discovery, entered a partnership last week to develop novel therapeutic antibodies using Genuv’s SHINE MOUSE platform. Under the terms of agreement, Genuv will conduct antibody discovery service using the SHINE MOUSE technology to be followed by research collaboration. According to Genuv, the SHINE MOUSE platform is able to generate a greater diversity of antibodies than conventional mice.
Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement | JD Supra
As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all claims in the case. Tanvez’s trastuzumab biosimilar has not yet been approved by FDA. Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars.
Hikma and Celltrion Announce Collaboration to Market Adalimumab Biosimilar YUFLYMA in Middle East and North Africa | JD Supra
On Monday, Hikma announced a partnership with Celltrion to market YUFLYMA (CT-P17) in the Middle East and North Africa. CT-P17 is a high-concentration, low-volume and citrate-free adalimumab biosimilar, indicated for the treatment of a number of conditions including rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease. According to Hikma, CT-P17 provides pain-reducing features and causes less pain upon injection.
Alvotech and STADA Launch HUKYNDRA® (Biosimilar of HUMIRA®) in Europe | JD Supra
Alvotech and Stada recently announced the launch of HUKYNDRA® to patients in certain European countries, including France, Germany, Finland, and Sweden. HUKYNDRA® is a biosimilar of HUMIRA® (adalimumab) developed by Alvotech and is authorized for the treatment of a range of inflammatory conditions including psoriasis, Crohn’s disease, and ulcerative colitis.
Q1 2022 Earnings Roundup: Biologics and Biosimilars Update | JD Supra
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.
Alvotech and AbbVie Resolve Disputes Relating to Alvotech’s Adalimumab Biosimilar in Europe | JD Supra
Alvotech Holdings S.A. (“Alvotech”) announced today that it has resolved all intellectual property disputes with AbbVie in Europe related to Alvotech’s AVT02 (adalimumab) biosimilar candidate.
Parties in Amgen v. Hospira Pegfilgrastim Litigation Stipulate to Dismissal of All Claims | JD Supra
On March 19, 2022, the parties in the Amgen Inc. v. Hospira Inc. (D. Del., No. 20-201) NEULASTA®/pegfilgrastim litigation submitted a stipulation to dismiss all claims and counterclaims in the litigation with prejudice. The Court (Judge Connolly) entered the order of dismissal on Monday. The case has been pending since February 2020. Hospira Inc.’s NEULASTA® biosimilar, NYVEPRIA®, was approved by the FDA on June 10, 2020. NYVEPRIA® is one of four pegfilgrastim biosimilars approved in the US.
Biocon Biologics Ltd. To Acquire Viatris Biosimilars Portfolio | JD Supra
On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. SEMGLEE (insulin glargine-yfgn) injection launched last year in the U.S. as the first-ever interchangeable biosimilar approved by the FDA. Viatris’ portfolio , a biosimilar to AbbVie’s HUMIRA (adalimumab).
Recent Insulin Glargine Biosimilar Developments | JD Supra
On Monday the FDA approved Eli Lilly’s insulin glargine biosimilar Rezvoglar, a biosimilar to Sanofi’s Lantus. Rezvoglar is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Rezvoglar is available in 3 mL prefilled pens and is administered subcutaneously once daily. Rezvoglar is the second Lantus biosimilar insulin product approved in the U.S., following the launch of Semglee last month.
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