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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
22-05-2025
- Business
- Korea Herald
Celltrion's Steqeyma gains wider insurance coverage in US
South Korean biopharmaceutical firm Celltrion announced Thursday that it has signed a second major deal with one of the top five pharmacy benefit managers in the US, securing private insurance coverage for its autoimmune disease treatment, Steqeyma (ustekinumab). Starting July 1, Steqeyma will be eligible for reimbursement through the newly secured PBM, significantly broadening patient access. This agreement follows an earlier deal finalized on April 3 with one of the top three PBMs in the US, giving Steqeyma a foothold in both public and private insurance formularies. With these two contracts, Celltrion now covers nearly 30 percent of the US pharmaceutical insurance market, which is an impressive milestone achieved within a month of the company's US launch. Celltrion's prior success with its other autoimmune treatments, such as Zymfentra and Yuflyma, has helped build trust among US health care providers. The company plans to leverage its expanded product portfolio for bundled marketing strategies, enhancing its competitiveness in the US market. According to pharmaceutical market research firm IQVIA, the global market for ustekinumab reached $21.6 billion in 2024, with the US accounting for nearly 77 percent. Celltrion aims to further strengthen collaboration with doctors, insurers and patient groups to ensure broad access to Steqeyma.
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
13-03-2025
- Business
- Korea Herald
Celltrion launches Stelara biosimilar in US
South Korean biopharmaceutical company Celltrion announced Thursday that it has launched Steqeyma (ustekinumab), a biosimilar treatment for autoimmune diseases, in the US market. Steqeyma, a biosimilar of Johnson & Johnson's blockbuster drug Stelara, received full-label approval from the US Food and Drug Administration last December for plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. The treatment is available in intravenous and subcutaneous formulations, allowing for flexible dosing options based on patient needs. Celltrion is launching Steqeyma at an 85 percent lower wholesale acquisition cost, or WAC, than Stelara. The company said this pricing strategy is expected to enhance profitability in the US insurance market, where high rebate rates are common. The company also aims to attract major pharmacy benefit managers and uninsured patients under the lower WAC version with reduced rebates. Celltrion is currently under negotiation with leading PBMs, including the three largest in the US, with some contracts nearing completion. To accelerate early market penetration, Celltrion is leveraging its direct sales distribution network, which it previously built for its biosimilars, including Zymfentra and Yuflyma. 'We are implementing an aggressive marketing strategy from the very start to secure early market share,' said Kim Bon-joong, CEO of Celltrion USA. 'With our expanding product lineup, we expect strong growth and aim to solidify our position as a leading provider of autoimmune disease treatments in the world's largest pharmaceutical market.' According to pharmaceutical market research firm IQVIA, the global ustekinumab market was estimated at approximately $20.4 billion in 2023, with the US accounting for 77 percent of sales at $15.6 billion.
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.
