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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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
