Presentation (CTI)

OBJECTIVES: The APAC region's regulatory environment for biosimilars is fragmented, with inconsistent access & reimbursement frameworks, unlike the centralized systems in the US and EU. Challenges such as limited pricing controls, low physician awareness, and infrastructure issues hinder adoption. However, biosimilars are expected to generate substantial savings across APAC by 2030 through increased competition and access. Due to limited understanding of adoption trends, this study explores the key drivers and barriers influencing biosimilar uptake in APAC
METHODS: A targeted literature review was conducted to examine policies, prescribing guidelines, and reimbursement requirements for biosimilars across APAC countries. Major countries were compared using key variables and ranked to identify main factors influencing biosimilar adoption
RESULTS: Public reimbursement markets like South Korea & Australia lead in biosimilar adoption due to clear regulatory and pricing policies, facilitating stakeholder willingness to adopt biosimilars. In contrast, private markets such as India, where biosimilars are priced 30-40% lower than reference products, lack specific pricing guidelines and mandatory discount policies, with limited government subsidy coverage. Smaller nations, such as Vietnam, face additional challenges due to unclear distinctions between biosimilars and biologics and limited data requirements for proving biosimilarity. Patient awareness is low, with most relying on physicians' recommendations. Although government tenders exist, slow biosimilar adoption delays access
CONCLUSIONS: The APAC region stands at a pivotal juncture in the evolution of biosimilars, with the potential to significantly impact healthcare delivery. Countries like India and Vietnam face challenges (fragmented policies, limited pricing guidelines, and low awareness among physicians and patients) which impede widespread adoption. However, biosimilars are projected to generate substantial economic savings across APAC by 2030 through increased competition and access, enabling healthcare systems to reallocate resources to other critical areas. Implementing tailored strategies to address regulatory, economic, and educational gaps is vital for fostering a sustainable biosimilars market