South Korea’s Samsung Biologics said in a regulatory filing on Thursday that it plans to spin off its biosimilar business to become a pure-play contract development and manufacturing organization.
Samsung Epis Holdings will become a dedicated holding company for biosimilar developer Samsung Bioepis, which is slated to be its wholly owned subsidiary. The process will begin with the submission of a securities report on July 29, followed by a shareholders meeting on September 16 for final approval.
“By creating fully independent corporate structures, both Samsung Biologics and Samsung Epis Holdings will be better positioned to enhance competitiveness and strengthen their respective corporate and shareholder value,” according to the company.
The filing said the spin-off is meant to “completely dispel concerns raised by some customers regarding conflicts of interest, despite strict firewall operations” with Samsung Bioepis, which was established in 2012 as a joint venture between Samsung Biologics and Biogen, with Samsung Biologics acquiring Biogen’s remaining shares in 2022 for $2.3 billion.
Last month, Samsung Biologics announced strong first-quarter 2025 financial results, more than doubling its net and operating profit compared to the prior year period. Despite rising geopolitical and trade tensions, the company expects annual sales growth of 20% to 25% in 2025.
Earlier this month, Samsung Biologics announced that it signed a new manufacturing agreement worth 737.3 billion Korean won (approximately $518 million) with an undisclosed U.S.-based pharmaceutical company.
According to a regulatory filing, the contract is set to run through the end of 2031 and represents about 16.2% of the company’s consolidated revenue from 2024. Samsung Biologics did not specify which biologic drugs it would be producing under the new deal.
The announcement comes less than a year after the company revealed a $1.2 billion agreement with an unnamed Asia-based company, which will extend through 2037, as well as deals with a Europe-based pharma company for manufacturing services valued at over $668 million that are set to run through December 2031.
Samsung Biologics’ Plant 5 — the first facility at its Bio Campus II in Songdo, South Korea — became operational last month adding capacity of 180,000 liters and advanced technologies and digitalized features, including an integrated manufacturing execution system to enhance operational efficiency and quality. Plant 5 also applies end-to-end logistics automation across the entire site.
“While Plant 5 follows a standardized design intended to serve as a future guide, it integrates innovative infrastructure to support both established and next-generation processes with agility and efficiency,” the company said last week in a profile of the facility. “The core technologies, such as N-1 perfusion and Raman spectroscopy, along with advancements in digitalization, including computational fluid dynamics and digital twin technology, enable real-time data monitoring for clients.”
Samsung Biologics also plans to expand its manufacturing capacity with the construction of Plant 6 at the Bio Campus II in response to growing biomanufacturing demand.
