• Report highlights key progress and achievements across three pillars: access to medicines, R&D innovation, and product quality and patient safety
• 430,000 patients have been treated with Samsung Bioepis' biosimilars across 40 countries in 2023
• In 10 countries, our biosimilars have created social impact worth approximately 2.5 trillion KRW (1.9 billion USD) in 2023
• The company reaffirms its commitment to achieving Net Zero by 2050 as part of the global effort to tackle climate change; company's first report on Task Force on Climate-Related Financial Disclosures (TCFD) to be released in second half of 2024

INCHEON, Korea, June 25, 2024 (GLOBE NEWSWIRE) - Samsung Bioepis Co., Ltd. today issued its 2024 sustainability report, underscoring its progress toward building more sustainable and socially responsible practices in access to medicines, R&D innovation, and product quality and patient safety.

“In pursuit of our vision 'Passion for Health', we ensure that our environmental, social and governance responsibilities are systematically managed. This year's sustainability report reflects our ongoing efforts to deliver positive social impact to patients while maintaining transparency and accountability in all aspects of our operations,” said Christopher Hansung Ko, President and Chief Executive Officer at Samsung Bioepis. “Through our operations, we make sure that we're making positive contribution to the communities we serve and also fostering long-term value for all of our stakeholders including patients, communities and governments.”

The annual report provides a comprehensive overview of Samsung Bioepis' performance and management of the company's commitment to sustainability, and key highlights of the report are as follows:

1) Access to Medicines: In 2023 alone, Samsung Bioepis' seven biosimilar medicines have been used to treat approximately 430,000 patients across 40 countries. 2023 witnessed biosimilar launches across several therapeutic areas, including adalimumab biosimilar launch in the United States and ophthalmology and hematology biosimilar launches in Europe. Based on assessment across 10 countries, our biosimilars have been estimated to create 2.5 trillion KRW (1.9 billion USD) social impact by helping healthcare systems achieve cost savings and by improving patients and caregivers quality of life and work productivity.i

2) R&D Innovation: We are continuing to optimize our biosimilar development platform through Quality by Design (QbD), Tollgate Systems, and Failure Modes and Effects Analysis (FMEA). We are able to develop biosimilars more effectively at a faster speed through higher productivity of cell line development, optimization of scale-up system, automation of analysis methods, digitalization of data management, and computerized modeling for process development. In addition, we are expanding R&D into antibody drug conjugates (ADC) and cell and gene therapy (CGT) by collaborating with biotech companies for research and development of drugs to explore new business growth opportunities.

3) Product Quality and Patient Safety: We have implemented a very stringent quality management system which allows us to detect potential quality risks in advance and manage them effectively in a timely manner. This has allowed us to provide biosimilar medicines that are quality-assured from cell line development to commercial manufacturing. As a result, we have not received any warning letter from regulatory agencies, for 35 inspections which were conducted throughout 2021-2023.

In addition, Samsung Bioepis received two ISO certifications: ISO 27001 (Information Security Management System) and ISO 45001 (Occupational Safety & Health Management System) in August 2023, underscoring the company's commitment to providing healthy and safe workplace environment and ensuring information security. Since 2022, together with Samsung Biologics, Samsung Bioepis is committed to achieving Net Zero by 2050, as part of the global effort to tackle climate change. At the heart of the commitment is achieving net zero carbon emissions (Scope 1 & Scope 2) by converting our direct and indirect energy sources to renewable energy in mid-to-long term.

The company's report is formulated in the Global Reporting Initiative (GRI) Standards and details activities and achievements that are aligned with the Sustainability Accounting Standards Board (SASB) Standards. Samsung Bioepis' detailed ESG performance can be found in the full report: https://bit.ly/3L0i7CM

Assessing our ESG Impact

Samsung Bioepis has been conducting a double materiality assessment to assess and prioritize 10 material issues: 1) product responsibility and safety, 2) access to medicines, 3) supply chain ESG risk management, 4) R&D and product innovation, 5) ethics and compliance management, 6) climate change, 7) governance, 8) human resources and talent management, 9) product lifecycle quality management, and 10) ethics for clinical trial and animal testing. These issues are assessed based on both financial and impact materiality, and are being managed based on key metrics and targets set for each issue. We also engage with our stakeholders – customers, employees, suppliers, vendors, investors, shareholders, academic institutions, local communities, governments, media, and trade associations – and incorporate their feedback when assessing the material issues and our ESG performance.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

MEDIA CONTACT
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

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i 10 countries are the United States (US), Germany, France, Italy, Spain, United Kingdom (UK), Republic of Korea, Canada, Australia, and Brazil.

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