First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report

摘要

Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety and efficacy of treatment. To discuss biosimilar regulation and approval across Southeast Asia, GaBI held the First ASEAN Educational Workshop on Regulation and Approval of Biosimilars/Similar Biotherapeutic Products in July 2017, in Thailand. This provided a forum to exchange knowledge on best practice and quality assessment related to biosimilar approval.