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…
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. …
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…