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…
Last week, Bio-Thera Solutions announced that a first patient has been dosed in its Phase III clinical trial study for ustekinumab biosimilar BAT2206. Stelara® (ustekinumab) is marketed by Johnson & Johnson Corp. for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease…
As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent information provided to an applicant during the patent dance. As of the effective date of June…
On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions that charge various agencies with tasks to promote generic and biosimilar competition. The Order directs the Food…
On July 6, 2021 Alvotech announced the start of a comparative, confirmatory efficacy and safety clinical study comparing AVT04, Alvotech’s proposed ustekinumab biosimilar, to the reference product STELARA, in patients with moderate-to-severe chronic plaque psoriasis. The announcement states that the study is being conducted in five countries in Central and…
Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a bevacizumab biosimilar injection, as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (“HCC”). According to the press release,…
On July 1, 2021, twenty-eight patient advocacy groups submitted a letter demonstrating their support for the BIOSIM Act (H.R. 2815). The legislation was introduced on April 22, 2021 with the purpose of increasing Medicare payments for biosimilars for a five-year period. The letter praises the BIOSIM Act as “critical to…
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents. Yesterday, the parties filed a Joint…
On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40…
This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD). On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the…