Samsung Bioepis has released its  Sustainability Report 2025  and its  databook , offering a transparent look into the company’s efforts to drive positive social and environmental impact. Covering performance from January 1 to December 31, 2024 – with select updates through April 2025 – the report is aligned with global standards including the Global Reporting Initiative (GRI) Standards, the Sustainability Accounting Standards Board (SASB), the Task Force on Climate-related Financial Disclosure (TCFD), the European Sustainability Reporting Standards (ESRS), the principles of UN Global Compact (UNGC), and others. This year’s report highlights how Samsung Bioepis is translating its “Passion for Health” into real-world progress – broadening access to medicines, advancing responsible innovation, and building a more sustainable future within biopharma industry. Check out the new findings in the report: 

2024 Business Highlights: Broadening Patient Access

Our biosimilars portfolio saw continuous growth with 11 approved in total and nine launched in selected markets – allowing for our biosimilars be accessible in more than 40 countries, reaching about 508,000 patients globally.

Notably, we’ve seen our biosimilars generate approximately USD 3.5 billion in social value¹  through cost savings and improved quality of life for patients and caregivers with our broad range of biosimilars ranging from immunology, oncology, ophthalmology, hematology, to nephrology.   
 

R&D Innovation for the Next-generation

With advanced development methods – Quality by Design (QbD), Tollgate Systems, Failure Modes and Effects Analysis (FMEA) – and ongoing digitalization of processes, Samsung Bioepis continues to shorten product development cycle with uncompromised quality while minimizing risks that may occur in each step of the process. We are also expanding our research into antibody-drug conjugates (ADC) and cell gene therapies (CGT) by establishing proprietary gene therapy platforms and engaging in external partnerships.

Ensuring Quality & Safety 

We strictly abide by and monitor the guidelines of domestic and international regulatory bodies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS), and receive regular inspections from these regulatory authorities. In total, 36 inspections were conducted over the past three years, including nine in 2024, and zero warning letters were issued. As a result, Samsung Bioepis and our third-party production, lab, and research partners successfully achieved GxP certification. 

Environment Leadership 

Samsung Bioepis is committed to minimizing the environmental footprint while ensuring sustainability throughout the whole value chain including its own operations. As such, from 2025, we launched the Environmental Management Council under the leadership of the Chief Safety Officer (CSO). The Council will convene every quarter to discuss our annual company-wide environmental goals, implementation plans and specific measures to achieve these goals.

Societal Impact: E.P.I.S. Way

In 2025, we redefined our corporate culture to drive our next breakthrough towards becoming a global top-tier biopharmaceutical company. We have established E.P.I.S. Way as our renewed corporate culture initiative to move us forward in the next chapter of our collective journey.
  

 

Governance: Ethical Management 

In April 2024, we successfully passed the ISO 27001 surveillance audit through strong cross-functional collaboration and in-depth security reviews. To support this, we also conducted company-wide training to reinforce awareness and share updated security policies. 
 

The Sustainability Report 2025 demonstrates how Samsung Bioepis continues to turn its Passion for Health into meaningful action – expanding access to treatment, advancing innovation, strengthening safety and quality, and reducing environmental impact. With clear goals and measurable progress, the company is proving that delivering affordable biologics and building a more sustainable future can go hand in hand.