Korean pharma leader Celltrion's biosimilar push gains momentum

Celltrion's Plant 2/ Courtesy of Celltrion

Editor's Note: This article is the 11th installment in our series on Asia's top 100 companies, exploring the strategies, challenges, and innovations driving the region's most influential corporations.

SEOUL, March 19 (AJP) - South Korean biopharmaceutical firm Celltrion is making significant strides in the U.S. biosimilar market, a rapidly evolving and highly competitive sector, even as potential tariffs cast uncertainty over the industry’s future.

The company has started the year on strong footing, securing four approvals from the U.S. Food and Drug Administration as of March 19, with two additional applications pending.

Among its latest approvals are Omlyclo, a treatment for food allergies and asthma; Osenvelt and Stoboclo, both for osteoporosis; and Avtozma, designed for arthritis patients.

Biosimilars are biologic drugs developed to be highly similar to already approved reference products whose patents have expired. They offer a cost-effective alternative without compromising efficacy or safety.

On March 13, Celltrion launched Steqeyma, its biosimilar treatment for autoimmune diseases, including plaque psoriasis and Crohn’s disease, in the U.S. market.

“Celltrion is the leader in biosimilar transactions in South Korea and is poised to maintain a strategic advantage over domestic competitors,” said Nelluri Geetha, a pharmaceutical analyst at GlobalData.

Celltrion's biosimilar product Remsima/ Courtesy of Celltrion

Founded in 2002 by Chairman Seo Jung-jin, Celltrion has focused on developing biosimilars for blockbuster drugs nearing the end of their patent protection, supported by an expanding global distribution network.

The company’s first biosimilar, Remsima, a treatment for rheumatoid arthritis, was approved by South Korea’s Ministry of Food and Drug Safety in 2012.

However, its global rollout took longer, receiving FDA approval in April 2016 and European Medicines Agency approval in February 2017. Since then, Remsima has emerged as Celltrion’s flagship product.

In 2020, Celltrion announced plans to merge with subsidiaries Celltrion Pharm and Celltrion Healthcare. The merger was met with investor pushback amid allegations of accounting irregularities. Ultimately, Celltrion merged with Celltrion Healthcare in December 2023, while plans to integrate Celltrion Pharm were abandoned in August 2024.

In September 2024, the company established Celltrion Biosolutions, a contract development and manufacturing organization, aiming to offer tailored biopharmaceutical services. Celltrion reported annual revenue of 3.56 trillion won ($2.46 billion) in 2024, marking a 63.5 percent increase year-over-year, though operating profit declined by 24.5 percent to 492 billion won.

The company’s biosimilar segment grew by 57.7 percent to 3.11 trillion won, bolstered by both established and newly launched products.

Notably, sales of the Remsima product line surpassed 1.2 trillion won, accounting for 35.6 percent of total revenue. Remsima also achieved a historic milestone, becoming the first biosimilar to exceed the market share of its reference product, Janssen’s Remicade.

Despite its success, Celltrion faces looming challenges as the Trump administration weighs new trade policies.

In February 2025, President Donald Trump announced plans to impose a 25 percent tariff on pharmaceutical imports, a move that could disrupt Korea’s duty-free drug exports to the U.S. under the Korea-U.S. Free Trade Agreement. South Korea exported $1.5 billion worth of pharmaceutical products to the U.S. last year, representing 16 percent of its total pharmaceutical exports.

Any immediate shift in production to mitigate tariffs is unlikely. The Pharmaceutical Research and Manufacturers of America estimates that constructing a new biopharmaceutical manufacturing facility can cost up to $2 billion and take five to 10 years to become operational.

Celltrion chairman Seo Jung-jin (right) gives a speech at the 2025 JP Morgan Healthcare Conference held in San Francisco with his son and CEO of Celltrion Seo Jin-seok (left), Jan. 16, 2025. Courtesy of Celltrion

In response, Celltrion has implemented a series of preemptive measures to cushion the impact of potential tariffs.

The company announced on Feb. 19 that it had already transferred approximately nine months’ worth of inventory for products destined for the U.S. market. Additionally, it plans to leverage local contract manufacturing organizations to sustain its supply chain. For longer-term stability, Celltrion is also exploring the export of drug substances, which are subject to significantly lower tariffs, as a strategic workaround.

Speaking at the 2025 J.P. Morgan Healthcare Conference on Jan. 14, Chairman Seo reaffirmed the company’s commitment to making biopharmaceuticals accessible at reasonable prices.

“We will continue to develop both biosimilars and innovative new drugs. With our expanding portfolio, we aim to enhance corporate value and establish ourselves as a global leader in pharmaceutical innovation,” he said.

Celltrion's plant 2 at night time/ Courtesy of Celltrion

Kim Dong-young Business Reporter davekim0807@ajupress.com

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