Celltrion, Inc. (Korea Exchange: 068270), the South Korean biopharmaceutical manufacturer, announced its participation in United European Gastroenterology Week 2026, taking place from October 17 to October 20 in Barcelona, Spain, with an emphasis on subcutaneous infliximab, marketed as Remsima SC. The company will present clinical and real-world perspectives on treatment maintenance, monotherapy and switching strategies in Crohn’s disease and ulcerative colitis, while promoting a wider portfolio that includes intravenous infliximab, ustekinumab and adalimumab products.
The programme comes as Celltrion expands the commercial reach of Remsima SC and its related intravenous formulations in Europe. According to its second-quarter 2026 financial update, Remsima SC exceeded 32% market share across Europe’s five largest pharmaceutical markets, comprising Germany, France, Italy, Spain and the United Kingdom. The company also launched a ready-to-dilute liquid version of intravenous Remsima in Europe earlier this year, adding another formulation option to its established infliximab business.
At UEG Week, Celltrion will host an October 18 industry symposium chaired by Peter M. Irving of King’s College London. Additional expert sessions will examine Remsima SC monotherapy and the potential value of transitioning from intravenous induction to subcutaneous maintenance in patients with complex Crohn’s disease. The announcement identifies these educational activities but does not disclose a newly completed clinical trial or fresh numerical efficacy findings.
The company’s strategy is supported by existing Phase 3 maintenance studies demonstrating that subcutaneous infliximab can sustain disease control following successful intravenous induction. The commercial question is whether a broader choice of formulations can improve treatment convenience, strengthen physician relationships and support market share while maintaining appropriate safety and clinical outcomes.
What will Celltrion present at UEG Week 2026 in Barcelona?
Celltrion’s principal symposium is titled Navigating the Treatment Journey with Subcutaneous Infliximab Across Clinical Scenarios. Scheduled for October 18, the session will examine how subcutaneous infliximab may fit into different inflammatory bowel disease treatment pathways. Professor Peter M. Irving will chair the programme, which forms part of the congress’s industry-supported educational activities.
The company will also organize two Meet the Experts sessions at its exhibition booth. Irina Blumenstein of University Hospital Frankfurt will discuss clinical evidence and real-world experience associated with Remsima SC monotherapy. Gionata Fiorino of San Camillo-Forlanini Hospital in Rome will address early transition from intravenous induction to subcutaneous treatment, including considerations involving complex and perianal Crohn’s disease.
These topics are clinically relevant because patients with inflammatory bowel disease often require long-term treatment adjustments after achieving an initial response. Clinicians must consider disease severity, treatment history, inflammatory activity and the risk of relapse when selecting a maintenance strategy. Administration preference is one factor, but it does not replace the need for continued monitoring of disease control.
The sessions will provide opportunities for physicians to discuss treatment experience and interpret existing evidence. However, the announcement does not identify a new randomized study being presented with previously undisclosed response or remission figures. Conference participation should therefore be understood as scientific communication and commercialization activity, rather than a new regulatory or clinical efficacy milestone.
How does Remsima SC differ from conventional intravenous infliximab?
Infliximab is a monoclonal antibody that inhibits tumor necrosis factor alpha, an inflammatory signaling protein involved in several immune-mediated diseases. The medicine has been used for many years in conditions including Crohn’s disease, ulcerative colitis and rheumatoid arthritis. Conventionally, it is administered intravenously, requiring infusions at a healthcare facility or through an appropriately supervised service.
Remsima SC provides a subcutaneous alternative for eligible patients. Its fixed-dose formulation contains 120 mg of infliximab and is generally administered at regular intervals according to the relevant approved indication and local prescribing information. Celltrion describes the product as the first approved subcutaneous formulation of infliximab.
The difference is primarily the route and convenience of administration rather than a new therapeutic target. Patients receiving subcutaneous maintenance may be able to administer doses outside an infusion center after appropriate instruction. This can reduce dependence on recurring intravenous appointments, although actual convenience depends on a patient’s circumstances, preferences and ability to self-administer.
Subcutaneous delivery also changes the pharmacokinetic profile. Compared with intermittent intravenous infusions, repeated subcutaneous doses can produce more consistent blood concentrations, with fewer pronounced peaks and troughs. That characteristic may be clinically useful, but differences in drug exposure do not automatically establish superior long-term efficacy.
An essential distinction is that subcutaneous maintenance is not interchangeable with intravenous induction in every jurisdiction. In the United States, the product is marketed as Zymfentra and is approved for maintenance treatment of adults with moderately to severely active Crohn’s disease or ulcerative colitis after completing an intravenous infliximab induction regimen. The US label requires that induction step before subcutaneous maintenance begins.
What did the LIBERTY clinical trials establish about remission at Week 54?
The pivotal LIBERTY-CD and LIBERTY-UC studies provide the strongest randomized maintenance evidence supporting subcutaneous infliximab in inflammatory bowel disease. Both programmes involved patients who had undergone intravenous infliximab induction before entering the randomized maintenance period. This design is important because it tests continued disease control after initial treatment rather than efficacy of subcutaneous therapy as the first induction treatment.
In LIBERTY-CD, involving patients with Crohn’s disease, 62.3% of those assigned to subcutaneous infliximab achieved clinical remission at Week 54, compared with 32.1% receiving placebo during the randomized maintenance phase. The absolute difference was 30.2 percentage points. The result demonstrated a substantial advantage for continued active maintenance treatment within the studied population.
In LIBERTY-UC, 43.2% of subcutaneous infliximab recipients achieved clinical remission at Week 54, compared with 20.8% in the placebo group. The absolute difference was 22.4 percentage points. The trial also reported endoscopic and histological outcomes providing additional evidence that active maintenance treatment could control intestinal inflammation.
For ulcerative colitis, endoscopic-histologic mucosal improvement occurred in 35.7% of patients assigned to subcutaneous infliximab versus 16.7% receiving placebo. This distinction matters because symptom improvement does not always correspond with resolution of underlying inflammation. Evaluating both clinical and objective inflammatory outcomes provides a more complete picture of treatment response.
However, the randomized placebo comparisons should not be described as proving that subcutaneous infliximab is superior to continued intravenous infliximab. The trials primarily established the effectiveness of subcutaneous maintenance after induction, using a withdrawal-style comparison. Claims of superiority between formulations require appropriately designed direct comparative evidence.
Why are monotherapy and switching strategies important for Crohn’s disease treatment?
Infliximab may be used alongside immunomodulator medicines in selected patients to reduce certain immunogenicity concerns or support treatment effectiveness. However, combination therapy can introduce additional considerations involving infection risk, tolerability and cumulative immunosuppression. Clinicians therefore evaluate whether some patients can maintain adequate disease control without a companion immunomodulator.
The planned Remsima SC monotherapy discussion will focus on this clinical question. Monotherapy generally refers to using the biologic without another immunomodulating maintenance medicine, rather than necessarily beginning subcutaneous infliximab without an intravenous induction phase. These are different treatment concepts, and the distinction remains important when interpreting real-world experience.
Switching from intravenous to subcutaneous maintenance presents another decision point. Patients with established responses may prefer fewer infusion-center visits, while others may value supervised treatment or have clinical reasons to maintain their existing regimen. Disease activity, previous medication exposure and treatment adherence can affect the suitability of switching.
Perianal Crohn’s disease introduces additional complexity because patients may develop fistulas and other complications requiring coordinated medical and surgical care. Anti-TNF treatment has an established role in selected fistulizing disease populations, but management frequently requires specialist evaluation. Evidence from general Crohn’s disease maintenance studies cannot automatically establish equivalent outcomes for every perianal complication.
The UEG discussions may help clarify how physicians apply the available evidence to these situations. Nevertheless, expert experience and observational data are not substitutes for randomized comparisons where specific treatment strategies remain uncertain.
What does the European launch of Remsima IV Liquid add to Celltrion’s portfolio?
Celltrion obtained European Commission approval for its liquid intravenous infliximab formulation in November 2025 and introduced the product commercially during 2026. The formulation is available in 100 mg and 350 mg presentations and eliminates the reconstitution step required for conventional freeze-dried infliximab preparations. This gives hospitals another way to deliver the established intravenous medicine.
The company previously reported an operational study involving 21 hospital pharmacists and nurses across seven European countries. That assessment suggested the liquid formulation could reduce preparation time by approximately 51% and preparation-related costs by about 20% compared with the powder formulation. These are workflow estimates based on the evaluated settings, not evidence of improved patient efficacy or reduced clinical complications.
The liquid formulation also supports a broader commercial strategy by allowing Celltrion to offer intravenous induction, intravenous maintenance and subcutaneous maintenance options within its infliximab franchise. Having multiple formulations may help the company compete for hospital tenders while meeting different patient and provider preferences. However, product selection must remain consistent with the authorized indication and appropriate clinical circumstances.
Celltrion reported securing Nordic tender contracts associated with the liquid formulation, including arrangements in Denmark and Norway. These developments provide evidence that formulation changes can influence procurement even when the underlying active medicine remains unchanged. Tender success, however, does not necessarily translate into equivalent market share or profitability in every European country.
How do Steqeyma and Yuflyma strengthen Celltrion’s inflammatory bowel disease business?
Celltrion will also feature Steqeyma, its ustekinumab biosimilar, and Yuflyma, its adalimumab biosimilar, at UEG Week. These products target different biological pathways used in the management of immune-mediated inflammatory diseases. Their inclusion allows the company to engage gastroenterologists across treatment options beyond infliximab.
Ustekinumab targets the shared p40 subunit of interleukin-12 and interleukin-23, while adalimumab, like infliximab, inhibits tumor necrosis factor alpha. Both medicine classes have established roles in selected inflammatory bowel disease populations. Choice among them depends on factors including previous therapy, disease characteristics, safety and the approved indications of the specific products.
The wider portfolio could support commercial relationships with healthcare institutions seeking multiple biologic treatment options. Celltrion can participate in different procurement categories and offer physicians access to products addressing more than one mechanism of inflammation. However, a broader portfolio does not mean that the medicines are interchangeable or appropriate for the same patients.
The company must also compete with established reference medicines, other biosimilars and newer advanced therapies. These include treatments targeting interleukin-23, integrins and intracellular signaling pathways. As treatment options expand, biosimilar manufacturers increasingly compete on access, supply reliability, administration convenience and clinical confidence rather than price alone.
Why does the Remsima SC strategy matter to Celltrion’s financial performance?
Celltrion reported consolidated revenue of approximately KRW 1.394 trillion during the second quarter of 2026, increasing 45% from the same period a year earlier. Operating profit reached KRW 451.8 billion, up 86.3%, with an operating margin of 32.4%. The company attributed the improvement partly to growth in newer products and a more favorable sales mix.
Remsima SC has become an important contributor to its European expansion. According to management, the product exceeded 32% market share across the five major European markets during the second quarter. The company also reported continued adoption of Zymfentra in the United States, where its regulatory and commercial positioning differs from the European product.
The figure describes the company’s reported market position rather than an independently verified share of all inflammatory bowel disease prescriptions. Market share can be measured by sales value, volume or a defined product segment, and conclusions should preserve the original basis of the estimate. The available financial disclosure does not establish that Remsima SC accounts for 32% of the entire European IBD treatment market.
Celltrion’s broader financial performance has also benefited from newly launched products across immunology and other therapeutic areas. Management reported that newer products accounted for approximately 65% of biologics revenue during the quarter. The company maintained an ambition to exceed full-year financial targets as commercial expansion continued.
UEG Week supports that strategy by providing a setting for clinical engagement with physicians who influence long-term prescribing decisions. However, the event itself does not constitute a new product approval, and its incremental contribution to future sales cannot be quantified from the announcement.
What safety and access questions remain for wider subcutaneous infliximab adoption?
Infliximab is an established anti-TNF treatment, but it carries important risks associated with immune suppression. Product labeling includes warnings concerning serious infections, including tuberculosis and invasive fungal infections, as well as certain malignancies. Monitoring and appropriate patient selection remain essential regardless of whether maintenance treatment is administered intravenously or subcutaneously.
Patients may also experience injection-site reactions, hypersensitivity and other adverse effects. A convenient route of administration does not remove risks associated with the biological mechanism of the medicine. Treatment decisions must therefore consider both the patient’s clinical circumstances and the relevant local prescribing information.
Commercial access may also differ between countries. European markets have different reimbursement structures, procurement arrangements and rules governing biologic prescribing. The ability to self-administer a medicine could be attractive, but its actual uptake depends on payer policies, healthcare infrastructure and physician recommendations.
The most useful future evidence will examine whether patients remain in remission after switching, how often treatment needs to be changed and whether subcutaneous administration affects adherence or healthcare utilization. Such outcomes can help establish real-world value beyond the efficacy already demonstrated in randomized maintenance trials. They will also inform how Celltrion positions its intravenous and subcutaneous formulations within the same treatment franchise.
Celltrion’s UEG Week 2026 programme reinforces an established clinical and commercial strategy built around multiple infliximab formulations and a broader biosimilar portfolio. The strongest evidence supporting Remsima SC comes from the LIBERTY studies, while the upcoming expert discussions will address how that evidence can be applied in more complex treatment situations.
The next commercial test is whether Celltrion can convert its expanding European market position into sustained growth while meeting different healthcare systems’ clinical and economic needs. Future comparative and real-world evidence will help clarify the value of switching strategies, monotherapy and formulation choice. For now, the congress represents an opportunity to deepen physician engagement rather than the announcement of a newly demonstrated clinical breakthrough.
