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Alexion, Celltrion Notch Product Development Gains
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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
