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…
Last week, Alvotech closed out the year with an announcement that it is expanding its high-tech center in Reykjavik, Iceland. This high-tech center, which will almost double the size of the existing facility by the end of 2022, will house “biosimilar development, drug refills, offices and warehouse, in addition to…
On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab). According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara. NeuLara…
In an effort to enhance development of medical products for orphan diseases (or rare diseases), the U.S. Food and Drug Administration announced on October 8, 2020 that it awarded six new grants for clinical trial research, including a grant for ustekinumab (STELARA®) for the prevention of graft versus host disease. …
This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…
Over the last two weeks, NeuClone and Formycon announced updates regarding their respective ustekinumab biosimilars (reference product, Stelara). On October 17, 2019, NeuClone announced that it has launched a Phase I clinical trial of its ustekinumab product, NeuLara. NeuClone stated that the Phase I clinical trial is a “single-dose, double-blind, randomised,…
Earlier this month, Alvotech announced that it entered into an agreement with Fuji Pharma, giving Fuji Pharma the exclusive right to commercialize its biosimilar of Stelara® (ustekinumab) in Japan. The press release states that, in exchange for developing and providing Fuji Pharma with a commercial supply of its ustekinumab biosimilar, Alvotech will…