Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.
Celltrion companies have developed biosimilar forms of infliximab for subcutaneous and intravenous use, but now the Incheon, Republic of Korea—based Celltrion Group is developing what would be the world’s first oral infliximab formulation, a tumor necrosis factor–alpha inhibitor, for the treatment of inflammatory bowel disease (IBD).
Celltrion is doing this in collaboration with the United Kingdom—based Intract Pharma, which specializes in oral therapies.
“A technical alliance between Intract Pharma and Celltrion Group allows for the development of oral infliximab that is safe, highly efficacious, and convenient,” Celltrion Group said in a statement.
Intract will be responsible for development and clinical validation of the product. Celltrion will supply drug material and provide support.
Clearance for Trials
Intract said in a statement that the proposed oral infliximab product has UK approval to proceed to phase 1b/2a clinical trials in patients with IBD. Those trials are expected to commence in the second half of 2021, without a requirement for additional preclinical research or a clinical safety study.
Officials said the oral infliximab is expected to be stable at room temperature, “offering simple distribution, storage, and administration for patients at home.”
Based on this partnership, more oral antibodies could be developed, they added. “Collaboration between the two parties is expected to open new doors for the development of additional orally-delivered antibodies.”
“We anticipate that the oral infliximab product which we will co-develop with Celltrion Group will have an improved safety profile and will offer a less expensive biotherapeutic treatment for IBD. We are hopeful that the product will address a large proportion of the IBD market, potentially replacing steroid and immune-suppressive drugs in addition to capturing a large share of the biologics market,” said Bill Lindsay, CEO of Intract.
Celltrion Group includes Celltrion and Celltrion Healthcare. The 2 companies are interconnected and do research, development, and manufacture of biosimilars and other drugs.
Intract Pharma “has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients,” the company said.
Celltrion's infliximab (Rensima) is also being tested in the CATALYST trial as a possible inflammation control for patients with coronavirus disease 2019.
Biosimilars Gastroenterology Roundup: March 2025
April 1st 2025As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
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.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.