- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Celltrion's COVID-19 Antibody Treatment Moves Into Phase 2/3 Trial
Celltrion moves another step forward in its bid to get a coronavirus disease 2019 (COVID-19) treatment on the market.
After receiving positive results from a phase 1 trial for its coronavirus disease 2019 (COVID-19) monoclonal antibody treatment (CT-P59), Incheon, Republic of Korea–based Celltrion Healthcare has received approval to initiate a phase 2/3 trial.
“Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilize our response to the pandemic. The initiation of the global phase II/III pivotal trial of CT-P59 is an important step forward,” said Sang Joon Lee, PhD, senior executive vice president at Celltrion, in a statement.
The news comes as Celltrion’s infliximab biosimilar (Remsima) is being tested in the phase 2 CATALYST trial to assess its efficacy in treating patients with inflammation linked to COVID-19 during hospitalization.
The phase 2/3 trial will be a global trial evaluating the safety and efficacy of CT-P59 in patients with mild-to-moderate symptoms related to COVID-19.
Celltrion, primarily a biosimilar developer and manufacturer, said it expects to have primary results for the phase 2 portion of the study by the end of 2020.
The company has filed an investigational new drug application for the trial in 6 countries, including the Republic of Korea, the United States, and Spain.
Celltrion said it plans to enroll more than 1000 patients in the multinational trial. Assuming the phase 2/3 trial yields positive results, the company expects to be able to apply for emergency use authorization.
“Celltrion has begun manufacturing the process validation batch of CT-P59 and plans to increase manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate,” the company said in a statement.
In addition to the phase 2/3 trial, Celltrion has initiated an ongoing in-human global phase 1 trial for CT-P59 in patients with mild cases of COVID-19. The company said it also plans to investigate whether CT-P59 is effective as a preventive treatment for those who are in close contact with patients with COVID-19.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
