Inflammatory Bowel Disease and Other Autoimmune Disease Treatments
World's First and Only 'Subcutaneous Injection' Drug
Expected Sales Growth Driven by Dosing Convenience and New Drug Advantages
Celltrion has launched Jimpendra (the U.S. product name for Remsima SC), an autoimmune disease treatment approved as a new drug by the U.S. Food and Drug Administration (FDA). Leveraging the advantages of being a new drug and ease of administration, the company aims for sales of at least 5 trillion won by 2030.
Celltrion announced on the 18th that it launched Jimpendra nationwide in the U.S. on the 15th (local time). The drug is used to treat moderate to severe active ulcerative colitis and Crohn's disease, which are types of inflammatory bowel disease (IBD).
Jimpendra is the first and only infliximab-based drug developed in a subcutaneous injection form. Infliximab is used to treat various autoimmune diseases, including IBD. Johnson & Johnson first developed it under the name Remicade and received FDA approval in 1998 for Crohn's disease treatment.
Despite the release of various similar agents over the past 26 years, infliximab still holds the number one market share in the U.S. IBD treatment market based on long-term efficacy and safety. However, attempts to develop a subcutaneous injection form with higher administration convenience have repeatedly failed, so it is still only used in the initial intravenous injection form. In the U.S., where medical accessibility is not very high, there is a particularly strong preference for subcutaneous injections that can be easily self-administered at home rather than intravenous injections that require visiting medical institutions each time. Given that infliximab-based drugs have maintained market dominance despite being supplied only as intravenous injections, expectations are high that Jimpendra, which adds ease of administration, will see even greater growth. In particular, if the patents currently being filed for the subcutaneous injection form and administration method are registered, it is explained that patent protection can be secured until 2040 at the latest, enabling stable profitability.
According to IQVIA, a pharmaceutical market research firm, the U.S. market size for IBD drugs with similar ingredients was $9.827 billion (approximately 13 trillion won) as of 2022. Celltrion plans to achieve a prescription rate of over 10% among target patients by 2025, the second year after launch, aiming to make Jimpendra a global blockbuster product with annual sales exceeding 1 trillion won. Earlier, Seo Jung-jin, Chairman of Celltrion Group, emphasized, "We can generate sales of up to 3 trillion won within three years," adding, "Even conservatively, it is a product that can reach 5 trillion won."
Doctors and patients are also placing their hopes on the drug. Jean-Fr?d?ric Colombel, Professor at the Icahn School of Medicine at Mount Sinai in New York, said, "IBD patients prefer treatments that are safe, effective, and also convenient to administer," adding, "In the U.S., patients can now manage their disease more flexibly and conveniently in daily life." Michael Osso, President of the Crohn's & Colitis Foundation, the largest IBD patient organization in the U.S., said, "IBD is a chronic, difficult-to-treat disease that places a significant burden on patients," and "With expanded treatment options for IBD patients, the ability to self-administer easily at home is a very meaningful advancement."
The wholesale acquisition cost (WAC) of Jimpendra is set at $6,181.08 for two doses (4 weeks). This is similar to the WAC of $6,576.50 for Yuflyma, Celltrion's currently marketed subcutaneous autoimmune disease treatment in the U.S. Celltrion explained that it established an optimal pricing policy that can operate an effective sales strategy by comprehensively considering Jimpendra's new drug status, competitor drug prices, and the characteristics of the U.S. market.
Sales will be directly handled by CelltrionUSA, Celltrion's local subsidiary in the U.S. Several small to mid-sized pharmacy benefit managers (PBMs) have already recognized Jimpendra's competitiveness and included the product in their formularies without separate negotiations. PBMs negotiate drug prices and rebate levels with pharmaceutical companies on behalf of public and private insurers in the U.S. and manage formularies, which are lists of drugs that can actually be prescribed. If a drug is not included in a PBM's formulary, sales in the U.S. are practically impossible.
In addition, Celltrion is continuing negotiations with major PBMs such as CVS Caremark, Express Scripts, and OptumRx, which collectively dominate about 80% of the U.S. PBM market, aiming to list Jimpendra as a preferred drug within the second quarter. PBMs categorize drugs into several tiers when adding them to formularies, and Celltrion aims for the highest tier, preferred drug status. Furthermore, Celltrion plans to participate in various conferences held in the U.S. this year to directly promote Jimpendra's product competitiveness to local medical professionals, and operate support programs that provide product discounts and supply assistance to patients with insufficient insurance coverage.
Thomas Nussbikel, Chief Commercial Officer (CCO) of CelltrionUSA, said, "Infliximab has already established itself as a proven treatment for IBD patients worldwide, including Europe, based on efficacy and safety," adding, "With the launch of Jimpendra in the U.S. market, which offers not only therapeutic efficacy but also a convenient treatment option, patients can now manage their disease more flexibly."
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