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…
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…
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…
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….
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year. As reflected by the assumption in the Company’s Full Year…
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. This announcement follows Alvotech’s announcement last month that the company had settled its pending disputes related to AVT02 with AbbVie in the U.S., and states…
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…
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…
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…
As we previously reported, Judge Connolly of the District of Delaware stayed the dispute between Amgen and Hospira last month, pending a determination on whether the Court should entertain summary judgment practice on the issue of noninfringement. Last week, the parties submitted a joint letter to the Court on the…