2025 was a landmark year for all stakeholders involved in biosimilars and especially for us at Samsung Bioepis. It was a year defined by strategic transformation, regulatory milestones, and deepened commitments to patients and partners worldwide. This year, the industry has witnessed a groundbreaking shift that will forever alter the outlook for biosimilars. As we reflect on the past year, we’re proud not only of the progress across our pipeline and commercial footprint, but also of the organizational evolution that will shape our next chapter of growth.

Organizational Evolution: Spin-off and new entities

A major strategic development this year was the successful spin-off of Samsung Bioepis from Samsung Biologics that established Samsung Epis Holdings and Epis NexLab. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings will optimize business strategies for its subsidiaries and maximize corporate and shareholder value through proactive R&D and investment. Epis NexLab will focus on transforming highly scalable core technologies into platforms for the discovery of diverse new drug candidates, including license-out or joint development with global pharmaceutical companies.

These moves create clearer focus across business lines and set the stage for faster, more flexible innovation while preserving our commitment to quality and access.

Innovating Access: Approvals and market launches

Our efforts to innovate access to biologic medicines continued through multiple approvals and launches across different regions:

*FDA: U.S. Food and Drug Administration

**EC: European Commission

Biosimilar Leadership: Partnerships and market reports

Partnerships remained central to our progress. These relationships help ensure patients receive timely access to high-quality biosimilars.
In January, we entered a partnership with Teva in the US to commercialize our eculizumab biosimilar in the US.
In June, NIPRO Corporation became our strategic partner in Japan and in July, we’ve entered a partnership with Harrow for the commercialization of our ophthalmology portfolio. In October, we’ve entered a partnership with Phrontline Biopharma for a global collaboration agreement to develop, manufacture and commercialize two antibody-drug conjugate (ADC) assets – a partnership that goes beyond biosimilars.

Our leadership in biosimilars extends beyond product development and commercialization. Since 2023, we have been publishing quarterly “US Biosimilar Market Reports” to help stakeholders better understand evolving trends, adoption dynamics, and opportunities across the biosimilar landscape. The report overviews the market status of all the biosimilars that are available in the US including approval and launch status, pricing (both Average Sales Price; ASP and Wholesale Acquisition Cost; WAC) after the Centers for Medicare & Medicaid Services (CMS) publishes updated quarterly ASP values for each product, and market uptakes per molecule.

If you’ve missed the report, you can see below the four reports from 2025.

- First Quarter 2025 Biosimilar Market Report

- Second Quarter 2025 Biosimilar Market Report

- Third Quarter 2025 Biosimilar Market Report

- Fourth Quarter 2025 Biosimilar Market Report

Biosimilar Thought Leadership: External and digital communications initiatives

In 2025, we also strengthen our external communications and thought-leadership presence. Our executives helped advance public dialogue on biosimilar policy, access, and sustainability of the healthcare market through influential platforms. Most notable were, fireside chat at the STAT Breakthrough Summit East in March by Gillian Woollett, Vice President of Regulatory Strategy and Policy, and fireside chat at the Reuters Total Health in October by Thomas Newcomer, Vice President and Head of US Commercial Operations. These engagements allowed us to share evidence-based insights with policymakers, clinicians, and industry leaders at a time of rapid market evolution.

In the digital space, we expanded our biosimilar leadership through our Re:Access initiative where Samsung Bioepis ‘Rethinks biosimilars as the answer to future healthcare Access’ and shared the issues within the biosimilar industry and the proposed solutions to foster a better healthcare ecosystem. This discourse was shared through our monthly newsletter on LinkedIn. To further extend our initiative, , Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, addressed the ‘biosimilar void’ on a podcast with STAT, highlighting what industry and stakeholders must do to ensure sustainable biosimilar competition as more biologics lose exclusivity.

Accomplishments: Awards and certificates

We were honored to have received numerous awards and certificates throughout the year being acknowledged by many stakeholders across various markets and field on the works that we’ve been doing for our patients, community and our colleagues.

The British Standards Institution (BSI) has given a certification on ISO 37301 (Compliance Management Systems), underscoring the company’s commitment to ensuring adherence to laws, regulations and ethical standards and fostering a culture of integrity.

The Korean Ministry of Health and Welfare has honored us the Health-friendly Workplace Certification, Leisure Friendly Certification, and Equal Employment Award on our commitment to a healthy work-life balance and supportive workplace culture.

Lastly, we were celebrated once again by Citeline for the ‘Biosimilar Initiative of the Year’ award at the Global Generics and Biosimilars Awards 2025. These accolades underscore the tireless passion of our team and our commitment to innovation, building and maintaining valuable partnerships, and advancing biosimilar solutions worldwide.

Looking Ahead to 2026

As we enter 2026, we remain focused on expanding our portfolio, advancing new biosimilar candidates, and ensuring sustainable competition in biologics. With more biologic therapies approaching loss of exclusivity globally, demand for high-quality accessible alternatives continues to grow and our combined organizational, regulatory, and commercial drive will help to meet that need.

Thank you for our partners, colleagues, and the global healthcare community for contributing to another year of meaningful progress. Together, we continue moving forward with one unified mission: to bring accessible, safe and effective biologic medicines to patients everywhere.