[Edaily Reporter KIM SAE-MI ] Celltrion(068270), which has reclaimed the top spot in Japan’s infliximab market for the first time in about 11 years, has created yet another formula for success in the anti-cancer biosimilar market. This is due to “Herjumma,” a treatment for breast and stomach cancer, and “Vexzelma,” used for metastatic colorectal cancer and non-small cell lung cancer, recording market shares exceeding 70% and 60%, respectively.

Although they operate in the same Japanese market and the same biosimilar business, the market strategies for Remsima, Herzuma, and Vegzelma differed. In areas such as inflammatory bowel disease (IBD), where the price competitiveness of biosimilars does not directly translate into reduced patient burden, Celltrion focused on building long-term trust with healthcare professionals. In contrast, in the oncology market, the company adopted a strategy of rapidly capturing market share through proactive sales and marketing efforts to fully leverage the price competitiveness of biosimilars.

This tailored approach—carefully analyzing disease-specific regulations and prescribing environments to devise distinct strategies for each product—is seen as the key reason Celltrion’s products have successively risen to the top of the market in Japan.

Price Competitiveness That Didn’t Work for IBD… Why Did It Succeed in Japan’s Anticancer Drug Market?

To understand the business environment for anticancer biosimilars in Japan, it is necessary to examine the Diagnosis-Procedure Combination (DPC) and Payment-by-Diagnosis-Group (PDPS) systems, collectively known as the “Japanese-style global payment system.”

DPC/PDPS is a system that pays a fixed daily amount based on diagnostic groups—classified according to diagnosis and treatment details—for acute-care inpatients. It is widely applied to inpatient cancer treatment, and certain medications used in this process, such as anticancer drugs, may be included in the comprehensive payment assessment. Therefore, assuming the same therapeutic effect, the more healthcare institutions use relatively inexpensive drugs, the more they can reduce their costs.

In the Japanese anticancer drug market, this creates an economic incentive for hospitals to choose biosimilars, which are less expensive than originator drugs. In fact, an analysis by Japan’s Ministry of Health, Labor and Welfare of biosimilar substitution rates by active ingredient showed that certain drugs with high usage rates in environments where comprehensive payment systems like DPC are applied tended to have high biosimilar substitution rates.

However, Celltrion is not the only company benefiting from this market environment. Competing biosimilars also compete under the same system. Ultimately, in addition to price competitiveness, how quickly a product can penetrate major medical institutions after launch and secure the trust and prescribing experience of healthcare professionals has become another key factor determining market share.

Price Alone Isn’t Enough to Be No. 1 in Japan… ‘Sales Capability’ Decided the Outcome

According to Celltrion, as of July of this year, the Japanese market shares of Herzuma and Begzelma stood at 78% and 64%, respectively. Both products maintain their positions as the top prescribers in the local market. Including Remsima, the total number of Celltrion products ranking first in prescriptions in Japan has increased to three.

The sales and marketing capabilities of the Japanese subsidiary are cited as the driving force behind these achievements. From the early stages of its business, Celltrion built a network by sharing product information and clinical data with major medical institutions and healthcare professionals, accumulating prescription experience to secure a leading position in the market.

Herjumma also responded swiftly to changes in the local treatment landscape. In August 2019, Celltrion received additional approval in Japan for Herjumma’s “Method B” regimen—administered at three-week intervals—for the treatment of HER2-positive breast cancer. This allowed the company to secure the same dosage and administration schedule as the originator drug for this indication, thereby broadening the foundation for prescription growth.

The connections with healthcare professionals and prescribing experience accumulated through oncology biosimilars were leveraged as assets to help subsequent products gain a foothold in the market. Celltrion continued to utilize the local sales network and brand awareness built through Herjumma even after the launch of Begzelma, thereby enhancing synergies across its oncology portfolio.

Lee Jun-hyuk, Team Leader at Celltrion Japan, explained, “Since the price competitiveness of biosimilars serves as a fundamental competitive factor in a DPC environment, the reason Herjumma and Begzelma were able to secure a leading position in the market is that we responded to market conditions more agilely than our competitors and built trust in our company and products among hospitals and healthcare professionals.”

From Remsima to Begzelma… Applying the “No. 1” Success Formula to Subsequent Products

Celltrion did not stick to a single formula for success in the Japanese market. In the IBD sector, where price competitiveness plays a limited role, the company adopted a strategy of building long-term trust with healthcare professionals by leveraging local partners and a direct sales organization. In contrast, in the anticancer drug market—where price competitiveness can also impact healthcare institutions’ cost management—the company focused on quickly capturing market share through proactive sales and marketing efforts.

As a result, following Remsima, Herjumma and Begzelma have also risen to the top of their respective prescription markets in Japan, bringing the total to three products. The local sales experience accumulated across different disease areas has become an asset that accelerates market entry with each new product launch. Celltrion also believes a “virtuous cycle” has been established, in which expanded product sales in Japan lead to increased brand awareness and preference, which in turn helps drive prescription growth for new products.

The company is also continuing to expand its product portfolio. Following the approval of its omalizumab biosimilar “Omriclo” in Japan this year, Celltrion completed its price listing in May. The company is currently preparing for the launch of “Remsima SC,” a subcutaneous (SC) formulation, scheduled for next year. Celltrion’s Japanese subsidiary aims to accelerate the growth of its Japanese business by expanding its prescription portfolio through the successive launch of new products while enhancing synergies with existing products.

Team Leader Lee emphasized, “The Japanese market has different regulations and prescribing environments depending on the disease area, so a one-size-fits-all strategy has its limitations.” He added, “We will continue to closely analyze the local market and implement business strategies tailored to the characteristics of each product to further strengthen the position of Celltrion’s product portfolio in the Japanese market.”