Samsung Bioepis focuses on the development of biosimilars, which are biologic medical products highly similar to already approved reference products. The company employs advanced scientific methodologies and rigorous quality control measures throughout the biosimilar development process. Their approach includes extensive analytical characterization, utilizing up to 80 different methods to assess the biological and physicochemical properties of the reference medicines. This thorough analysis ensures that the biosimilars meet critical quality attributes (CQAs) and maintain consistency across different production batches, thereby enhancing patient safety and treatment efficacy.

In addition to their analytical capabilities, Samsung Bioepis emphasizes innovative formulation strategies to improve the stability and delivery of their biosimilars. They utilize a Quality by Design (QbD) framework, which integrates risk management and systematic planning into the development process. This includes a tollgate system that assesses quality at each stage of development, ensuring that only products meeting stringent quality standards progress to commercial production. By focusing on patient needs and convenience, Samsung Bioepis aims to provide high-quality, affordable biosimilars that enhance patient access to essential therapies across various therapeutic areas, including immunology and oncology.

South Korea

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, endocrinology, hematology and nephrology. For more information, please visit: www.samsungbioepis.com.
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Samsung Bioepis

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