Tony Hagen is senior managing editor for The Center for Biosimilars®.
Alexion and Celltrion separately announce advances in their drug development and marketing efforts.
Alexion receives positive regulatory news in its bid to stay ahead of biosimilar competition, and Celltrion Group announces a phase 3 trial for its coronavirus disease 2019 (COVID-19) prophylactic drug candidate.
FDA Nod for Ravulizumab
Seeking to fend off biosimilar competition for its eculizumab originator product (Soliris), Alexion has received some aid in the form of FDA approval for a 100 mg/mL formulation of follow-on product ravulizumab (Ultomiris), for the treatment of nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The drug allows for reduced annual infusion times by roughly 60% vs Ultomiris 10 mg/mL.
Alexion said it plans an immediate product launch. The FDA decision comes less than a month after Alexion received a positive opinion from Europe’s Committee for Medicinal Products for Human Use in the same intravenous formulation.
Multiple biosimilar developers are working on competitor versions of eculizumab, including Samsung Bioepis, Epirus Biopharmaceuticals, and Amgen. Generium received Russian regulatory approval for an eculizumab biosimilar last year.
Phase 3 Trial for Anti–COVID-19 Drug
A monoclonal antibody advanced by biosimilar developer Celltrion Group as a preventative for COVID-19 has entered a phase 3 clinical trial. Celltrion aims to enroll 1000 patients to evaluate the prophylaxis capability of CT-P59 in patients exposed to SARS-CoV-2. Trial end points are prophylactic effect, safety, and whether CT-P59 can stimulate a sufficient antibody response to fight off SARS-CoV-2.
“We hope anti-COVID-19 monoclonal antibodies such as CT-P59 can provide high-risk individuals with effective protection against COVID-19 and help prevent further spread in the community,” said Dr Sang Joon Lee, senior executive vice president of Celltrion. “We look forward to continued data generation as this trial proceeds.”
The trial’s launch follows a go-ahead received from the Republic of Korea Ministry of Food and Drug Safety on October 8, 2020.