On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab). According to the press release, Formycon has acquired 100% of the rights in FYB202, a biosimilar candidate for STELARA®, and ATHOS’s 50% stake…
Amgen recently announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis. According to Amgen, the “study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and…
On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press release, SUSVIMO, previously called Port Delivery System with ranibizumab, offers an alternative route of administration for anti-VEGF in…
Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According to the press release, Bio-Thera will “maintain responsibility for development, manufacturing, and supply of BAT2206 [and] Hikma will have exclusive rights to commercialize…
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…
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…
On May 21, 2021, Meiji Seika Pharma Co, Ltd. announced that phase I clinical trials of DMB-3115, its proposed ustekinumab (STELARA®) biosimilar, demonstrated bioequivalence to reference products marketed in Europe and the United States. Meiji is co-developing ustekinumab under a 2011 strategic collaboration partnership agreement with Dong-A Socio Holdings. Phase III…
Earlier today, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB17, the company’s proposed biosimilar to Stelara® (ustekinumab). The trial will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and Stelara®. With the start of this trial, Samsung Bioepis has the following biosimilar candidates in…
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…
Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…