Latest news with #Remsima
Korea Herald
28-05-2025
- Business
- Korea Herald
Celltrion's Remsima SC hits fivefold growth in Europe
South Korean biopharmaceutical firm Celltrion announced Wednesday that the market share of Remsima SC, the subcutaneous formulation of the autoimmune disease treatment infliximab, has quintupled across Europe over just four years. According to the company, citing global pharmaceutical market research firm IQVIA, Remsima SC captured a 22 percent market share as of last year, surging from 4 percent in 2021 following its debut in 2020. When combined with the share of Remsima, the intravenous version, Celltrion's Remsima product line commanded a 71 percent market share in Europe. Celltrion noted that Remsima SC's success in Europe bodes well for the US market, given that its recent inclusion of Zymfentra — another brand name for Remsima SC in the US — in major US insurance formularies is expected to drive accelerated adoption. Celltrion's other autoimmune treatments are also making significant inroads in Europe. Yuflyma, its adalimumab-aaty biosimilar, secured a 21 percent market share last year. Meanwhile, its ustekinumab biosimilar, Steqeyma, launched in Europe in October, captured more than 2 percent market share within just a few months. 'Remsima SC's growing presence in Europe can be attributed to its convenience, treatment efficacy and tailored sales strategies from our local subsidiaries,' a Celltrion official said. 'With our existing products leading prescriptions in Europe, we plan to continue our growth through the launch of new biosimilars during the remainder of the year.'
Korea Herald
15-05-2025
- Business
- Korea Herald
Celltrion unfazed by US policy shifts: chair
Seo sees US pricing overhaul leveling playing field for biosimilars, affirms W5tr target revenue Celltrion Group Chair and founder Seo Jung-jin downplayed concerns over potential fallout from recent US policy and tariff changes, saying the South Korean drugmaker remains on track to meet its annual revenue target of 5 trillion won ($3.58 billion) this year. 'Concerns about the impact of recent US policy and tariff changes have been excessively amplified,' Seo said during an online briefing Thursday. 'We see no effect on our business this year, and even next year, it could be an opportunity rather than a risk.' His remarks come amid mounting investor unease over Washington's efforts to cut drug prices and adopt broader protectionist trade measures. Celltrion shares have fallen 16 percent this year, reflecting wider uncertainty across the sector. In a briefing aimed at addressing those concerns directly, Seo emphasized the company's preparedness to navigate shifting regulatory and trade dynamics. He said that Celltrion faces no immediate fallout from potential sector-specific tariffs, at least through next year. 'Celltrion has already secured inventory covering 15 to 21 months of US-bound supply,' he said. 'Whatever tariff measures are introduced, they won't affect us until the end of next year.' The company manufactures active pharmaceutical ingredients in Korea, while finished products are produced through contract manufacturing organizations in Europe and the US. Its US-bound biosimilars — including Remsima, Herzuma and Truxima — are sold via local partners such as Pfizer. Seo added that Celltrion has secured US-based contract manufacturing capacity for up to 3 million vials, with options to expand to 6 million if needed, providing flexibility to absorb potential tariff shocks. Still, he voiced caution over building an active pharmaceutical ingredients plant in the US. Constructing a 100,000 liter facility would cost about 1.3 trillion won in Korea, but is nearly 2 trillion won in the US, he said. 'We'll make a careful decision on US infrastructure investment once tariff policy becomes clearer, likely by year-end,' Seo said. Seo also said the US push to cut drug prices could ultimately benefit Celltrion. 'US drug prices are undeniably high compared to other countries, but that mainly applies to originator biologics,' he said. 'Celltrion focuses on biosimilars, so we're largely unaffected by pricing pressure.' He blamed inflated drug prices on the complex distribution chain of the US, where pharmacy benefit managers, insurers and wholesalers eat into the margin, creating inefficiencies. Although biosimilars are already sold at discounts of up to 90 percent compared to branded biologics, market penetration remains limited due to entrenched profit-driven intermediaries, he added. 'If the Trump administration simplifies the intermediary distribution system, it would create a more competitive market, one where Celltrion could thrive,' said Seo. While apologizing for the setback from the delayed launch of its new drug Zymfentra, Celltrion's key treatment for autoimmune diseases, in the US, Seo characterized the impact as minor and offset by other product sales. According to Seo, the company aims to expand its portfolio by launching 18 new biosimilar products by 2038, bringing the total to 40, while staying on course to begin clinical trials for 13 new drug candidates — including antibody-drug conjugates and bispecific antibodies — by 2035. Seo reaffirmed the group's full-year target remains intact. 'We're projecting between 4.6 trillion and 5 trillion won,' he said, expressing confidence earnings will rise quarter by quarter, charting a steady upward trajectory. Celltrion reached its target of 3.5 trillion won in revenue last year. Alongside earnings growth, Seo also pledged to boost shareholder returns and investor confidence. 'We will continue to repurchase and cancel treasury shares, with all newly acquired shares to be canceled,' he said, noting the company has already bought and canceled 450 billion won worth this year and plans to purchase up to 700 billion won more if needed. Toward the end, the chairman made a personal appeal to investors, reaffirming his long-term commitment to the company amid challenging times. 'I will do everything in my power to ensure stable and sustainable growth for as long as I live,' said the 67-year-old founder. 'I have no intention of selling this company or any part of my stake and plan to grow it and pass it on to my successors. I have about seven years left, and I intend to devote them entirely to Celltrion.'
Hans India
15-05-2025
- Business
- Hans India
South Korea's Celltrion expects minimal impact from Trump's drug pricing order
Seoul: Celltrion, a leading South Korean biopharmaceutical company, on Thursday said its business will remain largely unaffected by US President Donald Trump's executive order aimed at lowering drug prices to match those in other countries. The order seeks to address a drug pricing system in which the United States pays significantly more for prescription medicines than other developed nations, Yonhap news agency reported. "High US drug prices are not due to pharmaceutical companies, but rather the result of issues in the middle distribution process," said Celltrion Chairman Seo Jung-jin, in an online press conference. Trump's pricing proposal primarily targets intermediaries, such as pharmacy benefit managers (PBMs) and private-sector insurers, that drive up costs for US patients, he noted. Under the US PBM system, original biologic drugs are typically listed first in formularies, followed by the addition of two to three biosimilars through competitive processes. But the prices of biosimilars are often priced similarly to original drugs when prescribed in hospitals due to rebate issues involving intermediaries. "If the intermediary distribution structure that includes PBMs is overhauled, biosimilar manufacturers would be able to negotiate drug prices directly with the government instead of going through intermediaries," he said. "For Celltrion, this would generate more opportunities." Seo said the executive order will not likely affect the company's business, as its biosimilars are already sold at deeply discounted prices in the US market compared with original drugs. Regarding planned tariffs on pharmaceutical imports, the chairman also projected little impact on sales, noting that the company's flagship biosimilars -- Remsima, Herzuma and Truxima -- are not subject to import tariffs. The products are sold through Pfizer in the US market, and Celltrion holds sufficient inventories to supply the market for up to 21 months. The Trump administration plans to announce item-by-item tariffs on pharmaceutical imports within two weeks. "For continued growth, the company will also decide on whether to build a manufacturing facility in the US by the end of this year. We have already completed studies on 48 potential sites in eight US states for the project," Seo said, without elaborating. He forecast Celltrion will post between 4.6 trillion won ($3.29 billion) to 4.7 trillion won in sales this year, up from 3.56 trillion won last year. The company has significantly expanded its global biosimilar lineup, increasing the number of approved products from six to 11. It aims to commercialise 23 biosimilars by 2030 and 40 by 2038, while planning to put 13 original drugs under clinical trials by 2035. Celltrion currently sells its sole original drug, Zymfentra, in the US market for the treatment of self-immune diseases. The global market for its planned 23 biosimilars is expected to nearly double to 261 trillion won by 2030 from 138 trillion won this year, according to the company.
Korea Herald
18-03-2025
- Business
- Korea Herald
Celltrion unveils value-up program to boost growth, shareholder returns
Korean pharmaceutical giant Celltrion on Tuesday pledged to achieve an annual growth rate of 30 percent and a return on equity of at least 7 percent by 2027, as part of its long-term initiative aimed at enhancing corporate value and boosting shareholder returns. For the next three years, the firm added it would maintain an average shareholder return rate of 40 percent. This year, Celltrion has set a revenue target of 5 trillion won ($3.45 billion), following record-high revenue of 3.56 trillion won in 2024. The company plans to accelerate growth by strengthening its market position in biosimilars, including Remsima and Truxima, while expanding its young portfolios, which saw its sales figures rise from 26.1 percent to 38.4 percent last year. The company also expects a significant reduction in the costs of goods sold, which declined from 63 percent in 2023 to approximately 45 percent within a year and aims to reach the 20 percent range by 2027. To enhance shareholder value, Celltrion will increase dividends, repurchase shares and cancel treasury stocks, targeting a 40 percent shareholder return ratio. The company will issue a record-high dividend of 750 won in cash and 0.05 shares per common share this year. 'With strong sales and portfolio expansion, we have introduced this program to reinforce our corporate vision and commitment to shareholders,' said a Celltrion official. 'We aim to become a global top-tier pharmaceutical company while ensuring shared growth with investors.'
Korea Herald
26-02-2025
- Business
- Korea Herald
Celltrion's Remsima hits W1.2tr sales milestone
Celltrion's autoimmune disease treatment, Remsima, has surpassed 1.2 trillion won ($837 million) in annual sales, making it the first product in Korean biopharmaceutical history to exceed the 1 trillion won global sales milestone. The biosimilar giant reported annual sales of 3.55 trillion won last year and an operating profit of 492 billion won. Its flagship product, Remsima, contributed 1.26 trillion won, making up around 35.6 percent of total sales, the company revealed on Wednesday. After its European launch in September 2013, Remsima achieved a 52 percent market share by the end of 2017, according to pharmaceutical market research firm IQVIA, overtaking the original product's market share for the first time among antibody biosimilars. In 2022, it also set a milestone as the first developed drug in Korea to receive regulatory approval in over 100 countries. Through its 40 overseas subsidiaries, Celltrion directly distributes pharmaceuticals and executes tailored sales strategies for each country. Meanwhile, the rapid growth of Remsima SC, the world's only subcutaneous formulation of infliximab, is also attracting considerable market attention. When Remsima SC was introduced in Europe in 2020, its market share was just 1 percent, but by the third quarter of last year, it had risen significantly to 21 percent, according to the company. Last year, Remsima SC was launched in the US under the brand name Zymfentra, and successfully set the stage for expanding prescriptions by securing listing agreements with three major pharmacy benefit managers controlling 80 percent of the country's insurance market. 'We will accelerate the launch of follow-up biosimilars, including Remsima SC, and continue pursuing successful new drug development in areas such as antibody-drug conjugates and multi-specific antibodies, aiming to create the second and third 'Remsima,'' a Celltrion official said.
