"Jimpentra Already Gaining Major Attention in the US... Will Quickly Secure Market"

Nusbikel CelltrionUSA CCO Interview
'3 Trillion Won Sales in 3 Years' Expected FDA-Approved New Drug
"Both Doctors and Patients Have High Expectations"
"PBM Listing, Substance More Important Than Timing"

"Jimpentra will establish itself as a new drug leading a fresh wave in the U.S. inflammatory bowel disease (IBD) market."

Thomas Nussbickel, Chief Commercial Officer (CCO) of Celltrion Healthcare's US subsidiary (Celltrion USA)
[Photo by Celltrion Healthcare]

Thomas Nusbickel, Chief Commercial Officer (CCO) of Celltrion Healthcare's U.S. branch (Celltrion USA), expressed high expectations for 'Jimpentra (generic name infliximab)' in a written interview with Asia Economy on the 6th, stating, "Based on its improved treatment efficacy and convenience, it will become a therapy that helps improve the quality of life for more patients in the U.S." This is the first official interview Nusbickel has conducted with Korean media since his appointment in February.

Jimpentra is a drug at the forefront of Celltrion, the integrated 'new drug development company,' with Chairman Seo Jung-jin confidently projecting '3 trillion KRW in sales within three years.' With a global sales forecast of as much as 5 trillion KRW by 2030, its anticipated U.S. launch in the first half of next year is expected to mark the starting point of this journey.

On the 20th of last month, Jimpentra became the first domestically produced biopharmaceutical to receive new drug approval from the U.S. Food and Drug Administration (FDA). It is used to treat various autoimmune diseases, including IBD such as Crohn's disease (CD) and ulcerative colitis (UC). The main ingredient, infliximab, was first approved in 1998 as the first tumor necrosis factor (TNF)-α inhibitor. Although various TNF-α inhibitors have been developed over the past 25 years, infliximab still holds the number one market share 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 subcutaneous (SC) injection form with higher dosing convenience has not been developed, and treatment has continued with the initial intravenous (IV) form.

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

This is why Jimpentra, developed by Celltrion Group, which succeeded in developing the infliximab SC formulation that even the original developer could not, is receiving high expectations. Although Jimpentra is a biosimilar (a biopharmaceutical generic) and not a newly developed ingredient, the FDA highly valued the possibility of formulation change and even encouraged the submission of a new drug application first. Nusbickel CCO said, "Infliximab has played a central role in the U.S. IBD treatment market based on over 20 years of verified efficacy and safety data," adding, "Jimpentra, with the added competitive advantage of dosing convenience through the SC formulation, will quickly secure the market based on high patient preference."

Nusbickel CCO emphasized that both local doctors and patients have high expectations for Jimpentra. He said, "Inquiries about switching to Jimpentra have already begun," and "The gastroenterology association has proactively proposed collaboration, and we have confirmed significant interest and positive responses at academic conferences." Stephen B. Hanauer, a professor at Northwestern University's Feinberg School of Medicine and a leading expert in IBD in the U.S., also expressed expectations, stating, "Jimpentra showed high pharmacokinetic (PK) aspects such as clinical remission and endoscopic response rates, as well as convenience," and "The blood drug concentration is continuously maintained, which will improve patients' quality of life." Maintaining an appropriate drug concentration is essential for sustaining treatment effects in IBD. However, since IV dosing intervals are long at 8 weeks, there was a significant concern that drug concentration just before re-dosing would fall below the appropriate level, whereas SC dosing every 2 weeks allows for stable concentration maintenance.

Patients also show considerable anticipation. Michael Osso, president of the Crohn's & Colitis Foundation (CCF), a major IBD patient organization, said, "IBD patients experience significant burdens in their daily lives," adding, "It is a very meaningful development that treatment options for IBD patients have increased and that self-administration at home has become possible through Jimpentra." Besides treatment efficacy, Jimpentra is expected to contribute to reducing burdens on the healthcare system and socio-economic costs. Nusbickel CCO stated, "The burden on healthcare providers will be alleviated, enabling efficient patient management and effective allocation of medical resources." Already in Europe, numerous papers have been published showing significant cost reduction effects related to patients' treatment expenses through 'Remsima SC.'

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 USA plans to actively market Jimpentra following its launch. They intend to participate in various academic conferences to promote the product's competitiveness and attempt diverse approaches such as patient support programs and educational support. Nusbickel CCO said, "Payors such as insurance companies are also showing interest in listing Jimpentra in formularies," adding, "We will conduct aggressive marketing to ensure Jimpentra is rapidly listed in multiple formularies."

He also expressed confidence regarding the approach to pharmacy benefit managers (PBMs), which had been an issue during the U.S. launch of 'Uplima.' Nusbickel CCO said, "We do not feel rushed," and emphasized, "Rather than the timing of PBM listing, the significance of the channel, whether the drug is listed as a preferred drug in formularies, and the details of contract agreements are more important," adding that they will steadily target the market with Jimpentra as well.

Drugs like Jimpentra and Uplima, which are self-administered SC formulations, require listing in formularies selected by PBMs acting on behalf of insurers for distribution and sales. Although Uplima faced concerns due to delayed formulary listing in its early U.S. entry, it has since been listed as a preferred drug in major PBMs such as Optum and VantageRx. Nusbickel CCO stated, "The key to PBM success is not just whether the drug is listed in formularies but whether it is listed as a preferred drug that can be practically prescribed and reimbursed," adding, "We will ensure Uplima is listed as a preferred drug in more formularies to make a meaningful difference."

Celltrion's biosimilar for autoimmune disease treatment, 'Uplima'.
[Photo by Celltrion Healthcare]

Since joining Celltrion USA in February, Nusbickel CCO has identified "strengthening commercial capabilities" as the most important focus. "To successfully establish a direct sales system in the world's largest pharmaceutical market, the U.S., we have been actively recruiting experts and focusing on capability enhancement," he said, adding, "We will increase communication with key payors such as insurers, PBMs, and specialty pharmacies to help integrated Celltrion establish itself as a top-tier pharmaceutical and bio company." He also expressed anticipation for capability enhancement through the ongoing Celltrion Group merger. He said, "Once merged, the headquarters' operations will expand and unify to cover drug development, production, and approval, enabling differentiated strategy formulation and benefiting commercial activities," but added, "Since there will be no changes to the U.S. branch's organizational structure, we will continue existing operations while actively leveraging the positive effects of the merger."

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