The race to find a way to knock down the coronavirus disease 2019 pandemic has attracted companies with stakes in the biosimilar game. The winner could take all.
Stymied in its attempts to move forward with construction of a $514 million biosimilars manufacturing facility in Wuhan, China, the origin of the coronavirus disease 2019 (COVID-19) outbreak, Celltrion is trying another business strategy that may tide it through the current global economic crisis: It has joined the hunt for an antiviral treatment for the coronavirus.
”By screening blood sourced from recovered patients in Korea, Celltrion has secured 300 potential antibody candidates to treat COVID-19, and work is underway to select the therapeutic antibodies that are most effective at neutralising the SARS-CoV-2, the virus responsible for COVID-19,” a company spokesperson said.
The race to find therapies effective against COVID-19 has attracted major pharmaceutical players. This week, Amgen, a large player in the biosimilars market, confirmed that it has partnered with Adaptive biotechnologies to develop human neutralizing antibodies targeting SARS-CoV-2. Amgen and Adaptive said they are finalizing financial details of the deal.
Celltrion is well along in this endeavor, having completed the initial phase of securing antibodies that show signs of being able to target SARS-CoV-2.
Celltrion expects this phase of the investigation to be complete by mid-April, after which “the most promising antibody will form the basis of a therapeutic antibody treatment that encourages production of antibodies that recognise and block the spike protein that the virus uses to enter human cells,” the spokesperson said.
“Once we have selected the one that most effectively neutralizes the COVID-19 virus among hundreds of the screened antibodies, we will roll out mass production of the therapeutic antibody treatment, with a view to starting human trials this July,” Ki-Sung Kwon, head of research and development at Celltrion, said in a release.
The company has said it remains strongly committed to construction of the Wuhan plant, for which an April groundbreaking had been forecast. But given the threat of the virus and the growing lockdown on movement, those development plans are on hold.
“While we remain strongly committed to the project, we are closely monitoring the situation and will continue to communicate with the officials of Hubei province,” a spokesman said earlier this week.
Investigation has ramped up across the pharma sector in response to the COVID-19 pandemic. Besides antibodies, companies are investigating repurposed antivirals and RNA interference, which involves blocking protein translation by selective degradation of its encoded messenger RNA.
Meanwhile, Amgen said it is working rapidly and using high tech to expedite progress on the COVID-19 front.
“After swiftly obtaining viral gene sequences from hundreds of patients, Amgen was motivated to use these insights and quickly pair them with our drug development and manufacturing capabilities. Working with Adaptive and using their viral-neutralizing antibody platform will expedite our ability to bring a promising new medicine into clinical trials as quickly as possible,” said Robert A. Bradway, chairman and chief executive officer at Amgen, in a statement.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
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.