Celltrion's 'Jimpentra' Aiming for 5 Trillion Won Sales by 2030... Set to Launch in February Next Year

Released 4 Months After October FDA Approval
Competing with SC Formulation Enhancing 'Dosing Convenience'

"Active Discussions with PBM"
"High Interest from Medical Staff and Patients"

‘Jimpentra’ (the U.S. product name for RemsimaSC), the world’s only infliximab subcutaneous (SC) formulation developed by Celltrion, will make its debut in the United States, the world’s largest pharmaceutical market, on February 29 next year (local time). Jimpentra is a drug at the forefront of the integrated Celltrion, a ‘new drug development company,’ with Celltrion Group Chairman Seo Jung-jin confidently projecting ‘3 trillion KRW in sales within three years.’ By 2030, global sales are expected to reach as much as 5 trillion KRW.

Celltrion's autoimmune disease treatment 'Zimpenetra'
[Photo by Celltrion]

Jimpentra is set to meet patients just over four months after becoming the first domestically produced biopharmaceutical to be approved as a new drug by the U.S. Food and Drug Administration (FDA) on the 20th of last month. The main ingredient of Jimpentra, infliximab, was first approved in 1998 as the initial tumor necrosis factor (TNF)-α inhibitor and has since been used to treat various autoimmune diseases, including inflammatory bowel disease (IBD) such as Crohn’s disease (CD) and ulcerative colitis (UC). Despite the emergence of various TNF-α inhibitors over the past 25 years, infliximab remains the number one ingredient in the U.S. IBD market based on long-term efficacy and safety. However, there has been a high demand for a formulation change since a more convenient subcutaneous injection (SC) form had not been developed, and treatment continued with the initial intravenous (IV) form.

Celltrion Healthcare, responsible for the sales of Jimpentra, explained that it has completed providing clinical data of Jimpentra to the majority of prescription benefit managers (PBMs) and is currently negotiating for its listing as a ‘preferred drug.’ They added that some PBMs actively engaged in discussions expect tangible formulary listing results around the launch of Jimpentra.

Drugs like Jimpentra, which are self-administered in SC form, must be listed on formularies selected by PBMs acting on behalf of insurers to be distributed and sold in the U.S. Thomas Nussbikel, Chief Commercial Officer (CCO) of Celltrion Healthcare’s U.S. subsidiary (CelltrionUSA), previously stated, “We will conduct aggressive marketing to ensure Jimpentra is rapidly listed on multiple formularies,” emphasizing efforts to achieve ‘substantial listings’ such as being registered as a preferred drug with actual prescription and reimbursement capabilities across many PBMs.

In February, at the Celltrion Healthcare booth set up at the European Crohn's and Colitis Organisation (ECCO 2023) held at the Bella Center in Copenhagen, Denmark, Professor Milan Lukas of Charles University in the Czech Republic (Director of Iscare Hospital) gave a presentation on Remsima SC during the "Meet the Experts" event. According to Celltrion Healthcare, about 170 people gathered that day to listen attentively to Professor Lukas's presentation.
[Photo by Lee Chunhee]

Celltrion Healthcare is also preparing various commercial activities aimed at successfully capturing the U.S. market for Jimpentra. First, marketing activities targeting healthcare professionals who actually prescribe the drug will be expanded, focusing on autoimmune disease specialists in the U.S. Starting with the Crohn’s and Colitis Congress (CCC) in January next year, followed by Digestive Disease Week (DDW) in May, the American College of Gastroenterology (ACG) in October, and the American College of Rheumatology (ACR) in November, Celltrion Healthcare plans to actively participate in major conferences. Through these efforts, they aim to promote Jimpentra’s product competitiveness to key stakeholders in the autoimmune disease field and expand prescriptions.

CCO Nussbikel said, “Inquiries about switching to Jimpentra have already begun,” adding, “The gastroenterology association has proactively proposed collaboration, and we have confirmed significant interest and positive responses at previous conferences.” Particularly, due to the nature of IBD, where maintaining an appropriate drug concentration is essential for sustained therapeutic effect, medical professionals have shown high interest in the SC formulation, which allows stable concentration maintenance. Unlike IV, which has an 8-week dosing interval and risks suboptimal drug levels just before re-administration, SC is administered every two weeks, enabling stable drug concentration maintenance.

Customized commercial activities targeting patients will also be implemented. Celltrion Healthcare plans to develop various programs to support Jimpentra-prescribed patients in collaboration with major patient associations in the U.S. Michael Osso, president of the Crohn’s & Colitis Foundation (CCF), a leading IBD patient organization, stated, “IBD patients experience significant burdens in daily life,” adding, “The increase in treatment options and the ability to self-administer at home through Jimpentra represent very meaningful progress,” reflecting high patient expectations.

U.S. patient associations have significant influence through various activities, including training and supporting autoimmune disease experts, providing education for patients and families, supporting patient participation in clinical trials, and fundraising for research. Celltrion Healthcare emphasized that it will expand communication not only with currently engaged patient associations but also with many more patient groups to increase Jimpentra’s prescription preference.

Additional local specialized personnel will be hired to handle the significantly increased commercial activities for Jimpentra. As CelltrionUSA will conduct direct sales, the number of sales specialists responsible for Jimpentra sales will be doubled by January next year compared to the current level, and the number of dedicated promotion and marketing personnel will be increased more than threefold to carry out more aggressive commercial activities.

Exterior view of Celltrion Healthcare headquarters building [Photo by Celltrion Healthcare]

A Celltrion Healthcare official said, “With the Jimpentra launch date set for February 29 next year, interest from doctors and patients is rising, and negotiations with PBMs are actively progressing, creating a positive atmosphere locally in the U.S.,” adding, “As a key blockbuster product driving integrated Celltrion’s ‘12 trillion KRW sales by 2030’ goal, we will do our best to continue expanding successful prescriptions in the U.S. by actively promoting Jimpentra’s unique strengths, including proven therapeutic efficacy and safety of infliximab, improved patient convenience with the SC formulation, and product competitiveness as the most prescribed drug among U.S. IBD patients.”

This content was produced with the assistance of AI translation services.