UCB Korea is seeking to rebuild momentum in Korea by putting patient access at the center of its strategy, after years in which several of its innovative therapies faced reimbursement delays or setbacks.
The issue has been particularly sensitive in rare and intractable diseases, where small patient populations often mean high treatment costs and where reimbursement can determine whether a therapy is realistically available to patients.
UCB Korea General Manager Edward Lee discusses the company’s focus on patient access, reimbursement strategy and Korea’s growing role in global clinical development during an interview at UCB Korea’s headquarters near Gangnam-gu, Seoul, in April. (Credit: UCB Korea)
Against that backdrop, UCB Korea is trying to regain growth momentum through a broader portfolio of immunology and rare disease treatments, while placing market access at the center of its Korean strategy, according to UCB Korea General Manager Edward Lee.
Lee, a second-generation Korean American and market access specialist with a doctorate in pharmacy, took the helm of UCB Korea in November last year, as the company began recording a series of regulatory and reimbursement milestones after a relatively quiet period in new drug launches.
Bimzelx (bimekizumab) was reimbursed and launched for psoriasis in June 2025, while Fintepla (fenfluramine), a treatment for Dravet syndrome, won approval from the Ministry of Food and Drug Safety (MFDS) in December 2025. Bimzelx also secured indication expansions for psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa.
For Lee, these developments mark more than portfolio expansion. They reflect UCB Korea’s attempt to narrow the gap between regulatory approval, reimbursement and real-world treatment access.
That focus has shaped Lee’s priorities since taking office, with UCB Korea working to expand approvals and reimbursement for its key portfolio. A product launch alone has limited meaning, he stressed, unless patients can continue treatment without excessive access barriers or financial burden.
“If the foundation for sustained patient access is established, financial performance will naturally follow,” Lee said.
UCB has long built expertise in neurology and immunology. Although treatment options have improved over the past decade, Lee noted that many patients still do not experience sufficient benefit from existing therapies.
In his view, future innovation should go beyond symptom control and aim to alter the course of disease while improving patients’ quality of life.
In Korea, Bimzelx is expected to be a key growth driver following its psoriasis launch and indication expansions. Fintepla’s reimbursement process is also viewed as an important turning point for the company’s rare disease portfolio.
Fintepla is being prepared for reimbursement under Korea’s linked approval, evaluation and negotiation system, a program designed to accelerate access to therapies for serious, rare and intractable diseases by connecting regulatory approval and reimbursement procedures.
Lee acknowledged that the process has not moved as quickly as some may have hoped, partly because the system remains in a pilot phase. Still, he views the policy direction as meaningful because it shows that the government recognizes the need to shorten the path from approval to reimbursement in severe rare diseases.
UCB Korea is continuing discussions with relevant authorities on Fintepla’s reimbursement and hopes the review will move in a direction that allows faster patient access.
The company is also preparing reimbursement discussions for Rystiggo (rozanolixizumab) and Zilbrysq (zilucoplan), two treatments for generalized myasthenia gravis. Despite Korea’s challenging reimbursement environment, UCB decided to bring its generalized myasthenia gravis portfolio to the country relatively quickly after considering unmet needs, the treatment environment and the possibility of reimbursement.
The renewed activity follows a relatively quiet period for UCB Korea’s new drug launches in Korea. Lee did not deny that the past decade left some gaps.
“As a global pharmaceutical company, UCB Korea has continued trying to introduce innovative therapies to Korean patients, but institutional factors and the reimbursement environment created challenges,” Lee said. “The company is now working to better demonstrate the clinical value and patient benefits of its products through stronger evidence.”
The epilepsy treatment area illustrates why access remains a sensitive issue for UCB Korea. Vimpat (lacosamide), UCB’s lacosamide epilepsy treatment, won approval in Korea in 2010 and was launched in 2011, but it failed to enter reimbursement for years because of pricing issues and was eventually withdrawn in 2018.
Later, a generic version entered reimbursement before the original product, making Vimpat a frequently cited example of how Korea’s pricing and reimbursement system could delay patient access to innovative epilepsy therapies.
Briviact (brivaracetam), another UCB epilepsy drug, was approved in Korea in 2019, but its reimbursement process also stalled. The drug reportedly passed the Pharmaceutical Reimbursement Evaluation Committee in 2020, but price negotiations with the National Health Insurance Service broke down. After the product failed to secure reimbursement, domestic generic versions later received approval and began moving toward market entry after the patent expired.
However, Lee believes Korea’s reimbursement system has improved significantly compared with the past. Based on policy changes and the company’s accumulated experience, UCB expects to respond more effectively to similar access challenges in the future.
“Because healthcare resources are limited, reimbursement discussions need to consider not only the treatment effect for individual patients but also patient population-level outcomes and broader social value,” he said. “UCB is therefore working to present not only phase 3 clinical data but also real-world data that can show treatment effects and cost-effectiveness in actual practice.”
For rare and intractable diseases, reimbursement approval is only the first step. Lee emphasized that the level of out-of-pocket payment after reimbursement is also critical, because high costs can still prevent patients from continuing treatment.
Drawing on his market access experience in the U.K. and the U.S., Lee explained patients often face difficult choices over whether to prioritize treatment costs or other daily needs within limited household budgets. Access discussions, he added, should therefore include both the scope of reimbursement and the level of patient benefit.
According to Lee, the broader patient journey also matters.
“Discussions should look beyond drug prices to include the burden associated with diagnosis, treatment maintenance, monitoring and care,” he said. “UCB Korea is also monitoring the government’s move to strengthen post-listing drug management.”
The company is reviewing the overall policy environment, including approval, reimbursement and post-listing management, as it shapes future launch strategies, he added.
Expanding Korea’s role in global clinical development
Korea’s role in UCB’s global clinical development strategy is also growing. Lee cited the country’s strong infrastructure and research capabilities in patient recruitment and data collection. UCB Korea is working to strengthen the conditions needed for Korea to be considered a first-in-preference country in global clinical studies.
The company is currently conducting 10 clinical trials in Korea across neurological and immunological diseases, including Dravet syndrome, psoriasis, generalized myasthenia gravis, palmoplantar pustulosis, systemic lupus erythematosus and myelin oligodendrocyte glycoprotein antibody-associated disease.
Beyond clinical research, Korea is important to UCB as a market with global competitiveness in manufacturing, production and development. Global UCB has a contract manufacturing partnership with Samsung Biologics, while UCB Korea continues to work with local companies in distribution and marketing.
Lee said Korea’s strategic importance is increasing as the country shows signs of positive policy change in new drug access. Korea also ranks among the top 15 global markets in terms of market potential, making it an important country when UCB considers launch priorities.
Building an organization around access and trust
Since taking office, Lee’s first priority internally has been communication with employees. He wanted to understand their views, perspectives and the challenges facing the organization before setting the direction for the Korean unit.
Lee described his leadership approach as one shaped by the ability to step back and consider situations from multiple perspectives. He recalled advice from his grandparents during childhood that, in difficult moments, it is better to pause and assess the situation rather than react immediately.
That view has carried into his work in Korea, where drug approvals, reimbursement decisions, pricing discussions and patient needs often converge. Lee wants to build trust inside the organization by listening to different views and making decisions that reflect broader context.
At UCB Korea, he has emphasized four operating principles -- clear expectations, fast and accountable decision-making, a culture that respects different voices and stronger collaboration.
The collaboration he envisions is not limited to internal functions such as regulatory affairs, medical affairs, market access and commercial operations. It also includes communication with patient groups, physicians, government agencies and other healthcare stakeholders.
The company’s recent achievements in Korea have been driven by employees who share a focus on patient-centered care, Lee said.
In the short term, UCB Korea plans to focus on launch excellence and reducing the time between approval and actual patient access. Over the longer term, the company aims to strengthen evidence generation to support decision-makers and take an end-to-end approach covering diagnosis, treatment and monitoring.
“UCB Korea’s ultimate goal is to deliver innovative therapies to patients more quickly,” Lee said. “We will continue working to address unmet needs among Korean patients based on patient centricity, and we hope stakeholders and decision-makers will continue to share interest in and understanding of this direction.”
Lee Han-soo
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