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ddregpharma

at DDRegpharma

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. As regulatory frameworks across the region continue to mature, it is essential for stakeholders—including pharmaceutical...

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