Samsung Bioepis welcomes the U.S. Food and Drug Administration (FDA)’s announcement to streamline the development of biosimilars and promote access to more affordable biologic therapies. This policy shift aligns with our mission to bring quality-assured, safe, and effective affordable biosimilar medicines to patients more rapidly.

By reducing clinical comparative efficacy study (CES) burden and enabling a single more efficient pathway for interchangeable biologics, the FDA’s statement and new draft guidance eliminates key hurdles that have long delayed the availability of lower-cost biologic alternatives. In addition, the FDA's guidance could encourage more developers to continue to invest future biosimilar portfolio which will help close the biosimilar void: a gap caused by limited biosimilar development for off-patent biologics due to high development costs.

Notwithstanding the lessening of the CES burden, Samsung Bioepis’ commitment to scientific excellence, rigorous regulatory compliance, and collaboration with regulators, payers, healthcare professionals and patients remain unchanged, and we will continue to advance with our biosimilar portfolio for a more sustainable future fueled by innovation and access.