The health and economic burdens of inflammatory bowel disease (IBD) in the United States are on the rise. A recent study estimates 2.4 million Americans – or nearly 1 in 100 Americans – have Crohn’s disease or ulcerative colitis.1 Not only do they suffer from IBD symptoms and flare-ups, but they also endure a higher number of hospitalizations, emergency room visits, and surgeries. In 2014, the economic impact of IBD in the U.S. was approximately $31.6 billion, which included direct healthcare costs and indirect costs related to absenteeism from work.2
With immunology as one of its key therapeutic areas, Celltrion USA is committed to meeting the need for affordable, accessible IBD treatment options. The company’s product portfolio includes the world's first biosimilar monoclonal antibody, which was developed by Celltrion and distributed by Pfizer in the U.S. market, to treat immune-mediated inflammatory diseases such as Crohn’s disease and ulcerative colitis. Since launching in the U.S. in 2016, the product has gained 31% market share, second only to the originator drug Remicade®.
With the establishment of direct distribution and marketing in 2022, Celltrion USA has built a commercial infrastructure to strengthen its focus on immunology. As a leading global biopharmaceutical company, we are dedicated to developing biosimilars and next-generation biologics that improve health outcomes for patients suffering from IBD, while also serving as a reliable partner to ensure quality and access.
Unlocking the Potential of Biosimilars
Since the FDA approved the first monoclonal antibody biosimilar in 2015, a total of 43 biosimilars have been approved and made available to American patients.3 Remarkably, however, biosimilar market share in the United States is still low – particularly for immunology drugs, which were among the first biosimilars to be approved. That is now changing as the best-selling biopharmaceutical in the U.S., adalimumab (Humira®), faces biosimilar competition after a 20-year monopoly.
With the aim to offer providers and patients more treatment options through increased accessibility and affordability, Celltrion USA launched its TNF blocker biosimilar to treat autoimmune diseases in July 2023 following its FDA approval in May 2023. More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation,4 and the availability of Celltrion’s biosimilar provided patients with one of the only biosimilars with a high-concentration, citrate-free formulation. Even more, Celltrion USA just announced in October 2023 that the FDA approved two doses of its adalimumab biosimilar, providing more dosing flexibility to meet the needs of patients and clinical practices.
Recently, Celltrion signed agreements with U.S. biotech company Rani Therapeutics to develop orally administered biosimilars. If approved, these drugs will use an oral delivery technology, known as the RaniPill® capsule, intended to replace the subcutaneous or intravenous injections of the biologics with oral dosing. These treatments for inflammatory diseases, such as IBD, could offer patients an alternative method of drug administration, potentially providing more convenience in their disease management.
Celltrion has a robust pipeline and anticipates launching at least one biosimilar product every year, reaching a total of 18 products by 2030 in the U.S. market.
Expanding the Biologic Marketplace
As part of our commitment to address unmet patient needs, Celltrion has expanded beyond biosimilars with its first novel therapeutic to the U.S. market. Celltrion's subcutaneous formulation of infliximab, ZYMFENTRA® (infliximab), received FDA approval in October 2023 as a new drug via the 351 (a) biologic license application (BLA) pathway. ZYMFENTRA* is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following induction treatment with intravenous infliximab.5
This subcutaneous infliximab is a milestone therapeutic for the TNF inhibitor class, representing a key innovation after approximately 20 years of infliximab intravenous (IV) availability. With its approval, ZYMFENTRA is the first and only subcutaneous infliximab available in the U.S. and has the potential for improved clinical outcomes, delivering stable elevated serum infliximab levels above the target therapeutic concentration level. Additionally, ZYMFENTRA may provide more convenience and flexibility, as it can be self-administered at home rather than requiring patients to travel to a medical office to receive intravenous therapy.
Celltrion has prioritized developing biosimilar formulations and novel therapeutics that respond to market demands, such as the growing number of American patients in need of safe, effective, and economical IBD treatment options. In bringing our patient-centric approach and focus on immunology to the U.S. market, we are proud to support the IBD community through improved quality of care and cost-saving benefits to the U.S. health system.
References
*ZYMFENTRA (infliximab-dyyb) U.S. Use and Important Safety Information
ZYMFENTRA is a prescription medicine indicated for maintenance treatment of:
It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS INFECTIONS and MALIGNANCY
Contraindications:
Warnings and Precautions
Common Adverse Reactions (≥3%)
Drug Interactions
For more information about ZYMFENTRA, see full Prescribing Information including Boxed Warning.
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