Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
Republic of Korea—based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
Omalizumab, developed by Novartis in partnership with Genentech, is a monoclonal antibody approved by the FDA to treat asthma and chronic idiopathic urticaria. The compound patent for the biologic, according to Securities and Exchange Commission filings, expired in 2018. However, Novartis, according to its annual report in 2018, holds additional patents on syringe formulations that will not expire in the US or EU markets until 2021 and 2024.
Celltrion says that it began development of its biosimilar in December 2018 and added that it hopes to be the first developer to launch a biosimilar of the molecule. In particular, Celltrion says that it is focused on the US market, which accounts for approximately 70% of the branded drug’s global sales.
The phase 1 trial will enroll an estimated 171 healthy adult volunteers for a randomized, double-blind, 3-arm, parallel-group, single-dose study to compare the pharmacokinetics and safety of EU-licensed Xolair, US-licensed Xolair, and the proposed biosimilar. The trial is expected to be completed in August 2020.
In addition to Celltrion, several other biosimilar developers are targeting omalizumab; Glenmark announced its phase 1 study of proposed biosimilar GBR 310 in 2018, and Sorrento Therapeutics has completed a phase 2 and phase 3 study of its STI-004. Additionally, Biosana this year received permission from Australian regulators to initiate a phase 1 trial of its BP001.
Meanwhile, Novartis has been developing another product that could help it retain a hold on the market for utricaria. In 2018, the drug maker announced that its ligelizumab would advance to phase 3 trials for the treatment of chronic spontaneous urticaria after it demonstrated a clear dose-response relationship and improvements over omalizumab.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
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.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.