Samsung Biologics to Spin Off Biosimilars Unit Amid Conflict Concerns

Separation of Biosimilar and Contract Manufacturing Businesses

Samsung Biologics, the South Korean contract development and manufacturing organization (CDMO), has announced plans to spin off its biosimilars development subsidiary, Samsung Bioepis, to address potential conflicts of interest. The restructuring will allow Samsung Biologics to focus exclusively on contract manufacturing, while a new investment holding company will manage the biosimilars business.

According to a corporate filing released on Thursday, the spinoff is tentatively scheduled for October 1, 2025, though the date remains subject to change. The newly created entity, provisionally named Samsung Epis Holdings, will assume full ownership of Samsung Bioepis, which specializes in the development and marketing of biosimilar drugs.

Financial Structure and Business Focus

Post-separation, Samsung Biologics will retain capital of approximately 1.16 trillion Korean won (about $840 million), while Samsung Epis Holdings will be capitalized at 622.1 billion won (around $450 million). Seung Ho Ryu, Executive Vice President of Business Support at Samsung Biologics, clarified that the company’s U.S.-based contract manufacturing business will remain the sole subsidiary under Samsung Biologics following the split.

Addressing Conflict-of-Interest and Market Perceptions

The decision to separate the biosimilar and CDMO units responds to industry concerns regarding conflicts of interest. Samsung Biologics contracts with numerous major pharmaceutical companies, while Samsung Bioepis develops biosimilars targeting branded drugs nearing patent expiry. Some industry observers mistakenly believe the two entities operate as one, fostering fears that Samsung Bioepis’s biosimilars compete directly with Samsung Biologics’s clients’ products.

Ryu emphasized that despite stringent firewall measures, such concerns persist and pose risks to the company’s business expansion. He also highlighted broader challenges including U.S. tariffs and proposed drug price regulations, prompting a proactive move to resolve the inherent conflict-of-interest risks.

Investor Implications and Strategic Outlook

Ryu pointed out that the spin-off could unlock value for investors by allowing clearer market differentiation and valuation of the CDMO and biosimilars businesses independently. Samsung Biologics will continue leveraging its successful CDMO model, while the new entity will pursue growth through research and acquisitions.

Samsung Bioepis’s Executive Vice President and Head of Corporate Management, Hyoung Joon Kim, confirmed that the biosimilars unit will maintain its focus on developing and launching new biosimilar therapies.

Strong Growth Trajectory Post-Pandemic

Unlike many of its CDMO peers that saw pandemic-driven growth slow afterward, Samsung Biologics has maintained steady expansion. Early in 2025, the company reported a 23% sales increase over 2024, reaching 4.55 trillion Korean won (approximately $3.3 billion), a performance attributed by CEO John Rim to expanded collaborations with pharmaceutical and biotech partners.

Samsung Biologics also secured a $518 million production contract in May 2025 with an unnamed U.S. pharmaceutical company, representing about 16.2% of its projected 2024 revenue. This follows a $1.2 billion contract inked in October 2024 with an unnamed Asian pharmaceutical firm, underscoring the company’s ongoing business momentum.

Highlights

• Samsung Biologics plans to spin off its biosimilars subsidiary Samsung Bioepis by October 1, 2025, subject to change.
• The new entity, Samsung Epis Holdings, will take full control of Samsung Bioepis, separating biosimilar development from CDMO contract manufacturing.
• The move addresses conflict-of-interest concerns between Samsung Biologics’s clients and Samsung Bioepis’s biosimilar products.
• Samsung Biologics will retain 1.16 trillion won (~$840M) in capital; Samsung Epis Holdings will have 622.1 billion won (~$450M).
• The spin-off aims to enhance investor clarity and unlock hidden value in each business.
• Samsung Biologics continues strong growth post-pandemic, with 23% sales growth in early 2025 and new significant contracts totaling over $1.7 billion in the past year.