[Edaily Reporter KIM SAE-MI ] Celltrion(068270) Celltrion’s flagship biosimilar, “Remsima,” has surpassed the originator drug to become the top-prescribed medication in Japan. While Remsima has rapidly expanded its market presence, particularly in Europe, it took approximately 11 years to reach the top spot in Japan. This achievement is the result of steadily building trust among healthcare professionals through local partners and a direct sales organization—a strategy necessary in Japan’s unique market environment, where the mere advantage of a lower-priced biosimilar is often insufficient to drive adoption.

According to data compiled by Celltrion on the 18th based on information from pharmaceutical market research firm IQVIA and local sources, Remsima recorded a 48% prescription share in Japan’s infliximab market last July.

This marks the first time Remsima has taken the top spot in the Japanese market, where a total of four infliximab products—including the originator drug—are competing. Celltrion attributed Remsima’s rise to the top, approximately 11 years after its launch in Japan, to a sales strategy tailored to the characteristics of the local market.

Japan’s IBD Market: Patients Don’t Feel the Benefits of Lower Biosimilar Prices

Generally, one of the biggest competitive advantages of

biosimilars

is

their

lower

price

compared to originator drugs. However, in Japan, depending on the disease, this price advantage does not always translate directly into actual prescriptions.

A prime example is the inflammatory bowel disease (IBD) sector, which includes ulcerative colitis (UC) and Crohn’s disease (CD). Japan operates a “High-Cost Medical Expense System” designed to reduce patients’ out-of-pocket costs, and both ulcerative colitis and Crohn’s disease are included in the Japanese government’s list of “designated intractable diseases.”

The High-Cost Medical Expense System is a program under which public health insurance covers the portion of a patient’s monthly medical expenses that exceeds a predetermined cap based on age, income, and other factors. As a result, for some patients using high-cost biologics, switching from the originator drug to a relatively less expensive biosimilar may not result in a significant difference in their out-of-pocket costs.

The “Designated Intractable Diseases” system is a mechanism designed to alleviate the financial burden of medical expenses by allowing patients with specific conditions to pay the lower of either the standard copayment rate or the monthly cap based on their income level. Consequently, even if drug prices decrease, that reduction may not fully translate into a decrease in the patient’s actual out-of-pocket costs, thereby weakening the economic incentive to switch to biosimilars.

Similar concerns were raised during an expert roundtable held by the Japan Biosimilars Council in 2020. Kenji Watanabe, then Director of Internal Medicine at the Center for Inflammatory Bowel Disease at Hyogo College of Medicine, noted, “Because the out-of-pocket maximum for IBD is very low under the medical expense support system, there are few cases where patients’ out-of-pocket costs decrease even after switching to biosimilars.”

Japan’s Ministry of Health, Labor and Welfare has also previously analyzed that, for certain active ingredients such as infliximab, the public medical expense support system could act as a factor that reduces the incentive to switch to biosimilars. In other words, the Japanese IBD market is an environment where it is difficult to compete based solely on the price competitiveness of biosimilars being cheaper than originator drugs.

“Grassroots Sales” Instead of Price… The 11-Year Battle That Led Remsima to the Top Spot

In this situation, Celltrion opted for

a long-term strategy

. Not only did it partner with domestic Japanese pharmaceutical companies, but it also launched its own direct sales system to minimize gaps in market coverage and drive the expansion of Remsima prescriptions.

Celltrion Pharm Inc. has devoted significant effort to developing a Japan-specific sales strategy tailored to the characteristics of the local pharmaceutical market. Recognizing the significant influence of domestic companies in the Japanese market, Celltrion selected Nippon Kayaku as a partner to help Remsima gain a foothold and expand prescriptions in the early stages. After accumulating an understanding of the Japanese market and sales know-how, and expanding its local professional workforce, Celltrion’s Japanese subsidiary also began full-scale sales of Remsima in late 2017.

This involved a two-track strategy that leveraged both a local partner and its own sales network. In Japan, where supply channels are highly segmented—ranging from large hospitals to small and medium-sized medical institutions—Celltrion Japan and its partner each focused on the channels where they held a competitive advantage, thereby minimizing sales blind spots, according to the company.

Currently, Celltrion Japan employs approximately 80 staff members, including dedicated sales personnel. This represents about 8% of the total workforce across all of Celltrion’s overseas subsidiaries. This indicates that the company has invested significant manpower in expanding its direct presence in the Japanese market over the long term.

Lee Jun-hyuk, Team Leader at Celltrion Japan, explained, “In the Japanese pharmaceutical market, sustained on-site sales efforts that take into account the characteristics of individual medical institutions and their decision-making structures are crucial.” He added, “Rather than engaging in simple price competition, we continuously expanded our engagement with healthcare professionals to build long-term trust, while consistently implementing sales and marketing strategies optimized for the local market environment—and this has led to Remsima’s success.”

Some observers note that this success stands in contrast to instances where global pharmaceutical companies have ceased direct sales of their drugs in Japan and handed them over to local firms.

Sanofi transferred the sales and marketing operations for “Zevtana” in Japan to Daiho Pharmaceutical in April. Zevtana is a prostate cancer treatment that Sanofi had been selling directly in Japan since its launch there in 2014. An industry insider interpreted this, saying, “This is an example that illustrates just how challenging local sales activities are in Japan—so much so that even global Big Pharma companies are giving up on direct sales there.”

Japan’s Biosimilar Policy Also a Tailwind… ‘Remsima SC’ Awaits Launch

Recent Japanese government

policies

are

also

moving in a direction favorable to biosimilars. Japan’s Ministry of Health, Labor and Welfare has set a goal of increasing the proportion of components where biosimilars account for more than 80% to over 60% of the total by the end of fiscal year 2029 and is promoting policies to expand their use.

Celltrion is strengthening its portfolio strategy in the Japanese autoimmune disease market, using Remsima as a springboard. Currently, in addition to Remsima, the company is marketing the adalimumab biosimilar “Uplima,” the tocilizumab biosimilar “Aptozma,” and the ustekinumab biosimilar “Stekima.” The company is also preparing to launch “Remsima SC,” a subcutaneous (SC) formulation, in Japan next year.

It remains to be seen whether Ramzyma’s top market position—secured for the first time in 11 years—will go beyond being merely the achievement of a single product and serve as a springboard to accelerate the market establishment of subsequent products.

Team Leader Lee said, “Since Celltrion possesses a diverse portfolio of competitive therapies—including Uplima and Aptozma in addition to Remsima—we plan to further refine our business strategies for each product to ensure that more patients in Japan can benefit from these treatments.”