2024-02-27-艾昆纬-Generics弥合制药和东盟市场的监管差距（英）_12页_810kb

Generics in Emerging Markets and ASEAN: Regulatory Challenges and Opportunities

Generics drugs are increasingly important as affordable alternatives to branded medicines, contributing significantly to cost savings and improved access in healthcare systems worldwide. The global generics market has grown steadily, with market share rising from 68.7% in 2018 to 71.5% in 2022 by volume, driven by factors such as rising healthcare costs and aging populations.

Several policies aim to promote generics use, including Bolar provisions that allow early market entry before patent expiration, reimbursement incentives, and demand-side strategies like generic substitution and educational campaigns. These measures help reduce costs and increase affordability, but they face implementation challenges and vary by region.

Key regulatory barriers include intellectual property (IP) protection, which delays generic market entry, and the lack of harmonized guidelines for bioequivalence (BE) assessments. Country-specific considerations in emerging markets involve navigating local regulations, stability requirements, and reimbursement models, which can extend approval times and costs.

Strategic regulatory planning is essential for successfully entering markets, leveraging opportunities from patent expirations while addressing cultural and political factors. Overall, generics play a crucial role in enhancing healthcare equity and sustainability, but bridging regulatory gaps requires collaborative efforts and local expertise to maximize benefits in pharmerging and ASEAN contexts.