Regulatory Landscape for Biosimilars in Southeast Asia

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Regulatory Landscape for Biosimilars in Southeast Asia

  • The biopharmaceutical landscape is at a pivotal moment as biosimilars—therapeutic products that closely resemble and are clinically equivalent to existing biologic drugs—gain traction. In Southeast Asia, a region characterized by diverse healthcare infrastructures and economic inequalities, biosimilars offer a transformative opportunity to enhance access to essential biologic therapies. Yet, their successful adoption into national healthcare systems depends heavily on regulatory readiness and cross-border alignment.

Regulatory Landscape for Biosimilars in Southeast Asia


  • As regulatory frameworks across the region continue to mature, it is essential for stakeholders—including pharmaceutical companies, regulatory professionals, healthcare providers, and policymakers—to grasp both the shared features and country-specific nuances of biosimilar approval pathways. In this blog, we examine the current biosimilar regulatory landscape in major ASEAN countries, highlight key challenges, and discuss strategies to build a robust and sustainable biosimilar ecosystem.

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