[Lim Jeong-yeo, Edaily Reporter] Celltrion’s autoimmune disease treatment Remsima(infliximab) surpassed annual sales of 1.26 trillion won($950 million), becoming the country’s first homegrown blockbuster drug, the company said Wednesday.

While a global blockbuster drug refers to those with annual sales above $1 billion, the Korean industry sets the threshold at 1 trillion won. Remsima reached the Korean milestone, highlighting the growing international competitiveness of South Korean drug manufacturers, Celltrion said.

Remsima(Celltrion)

As the world’s first antibody biosimilar, Remsima played a pivotal role in shaping the global biosimilar market for antibody-based therapies. Following its introduction, major pharmaceutical companies worldwide accelerated the development of biosimilars for biologics nearing patent expiration.

Remsima is now the first biosimilar to surpass the market share of its original reference drug. After its European launch in 2013, the drug reached a 52% market share by the end of 2017, according to IQVIA data. In 2017, it also became the first South Korean drug to exceed 1.2 trillion won in global prescriptions, marking a significant achievement for the country’s pharmaceutical sector. By 2022, Remsima obtained regulatory approvals in over 100 countries, further solidifying its status as a globally recognized treatment.

Celltrion attributes the success of Remsima to its superior treatment efficacy and direct sales strategy. Unlike many pharmaceutical companies that rely on local distributors, Celltrion operates an extensive global direct sales network, allowing it to tailor its marketing strategies to the unique characteristics of each country’s pharmaceutical market. Currently, Remsima is sold through 40 overseas subsidiaries, each implementing customized sales strategies to maximize market penetration.

Beyond its intravenous(IV) formulation, Remsima’s subcutaneous(SC) version, Remsima SC, is experiencing rapid growth. When first launched in Europe in 2020, Remsima SC held a mere 1% market share. However, by the third quarter of 2023, its market share surged to 21%, reflecting increasing adoption among patients and healthcare providers. A growing number of patients who initially transitioned from competitor products to Remsima are now opting for Remsima SC for long-term maintenance therapy, a trend that suggests continued sales growth in the coming years.

In 2023, Celltrion introduced Remsima SC in the U.S. under the brand name Zymfentra. The company successfully secured reimbursement agreements with the three largest pharmacy benefit managers (PBMs), which control 80% of the U.S. insurance market, significantly expanding patient access to the drug. To further boost awareness, Celltrion launched media campaigns, including television and YouTube advertisements. With growing preference among physicians and patients, the company expects Zymfentra’s sales in the U.S. to accelerate throughout 2024.

A Celltrion spokesperson described the recognition of Remsima as South Korea’s first global blockbuster drug as a historic moment for the country’s pharmaceutical industry. The company will not rest on its success, he said, adding that in addition to expanding its biosimilar portfolio, Celltrion is investing in next-generation treatments, including antibody-drug conjugates (ADCs) and multi-specific antibodies. The spokesperson emphasized that the company is committed to continued innovation and aims to develop the next generation of blockbuster biologics.