Background
Biologics have transformed the treatment of chronic diseases, but their high-cost limits access and burdens healthcare budgets. Biosimilars, highly similar versions of approved biologics, offer a more affordable alternative. However, their complex nature necessitates distinct regulatory and clinical guidance to ensure their safe and effective use in the healthcare facilities.
Objective
This article highlights the policy initiatives undertaken by the Ministry of Health (MOH) Malaysia to develop a Position Statement, aimed at guiding the integration of biosimilars into Malaysia’s public healthcare system.
Method
A multi-stage process began in 2019 and involved structured stakeholder engagement, literature reviews, and consensus-building across medical and regulatory disciplines. Key areas addressed included interchangeability, switching, automatic substitution, prescribing, procurement, and pharmacovigilance. Two rounds of review were conducted, and stakeholder consensus was obtained through a binary survey, with a 70 % agreement threshold.
Results
Stakeholders from multiple specialties emphasized cautious but positive attitudes toward biosimilar use, especially for treatment-naïve or short-term therapy patients. The final guidance includes ten statements across five domains, emphasizing physician-led switching, prohibition of automatic substitution, indication-specific prescribing, and the need for robust pharmacovigilance. A total of 83 % of stakeholders supported the content, and 88 % endorsed its dissemination. The document was officially endorsed by the MOH Medicines Formulary Panel for implementation across all MOH facilities.
Conclusion
The position statements represent a critical step toward structured biosimilar adoption in Malaysia’s public healthcare. Ongoing implementation, education, and post-market evaluation will be essential to strengthen prescriber confidence, improve pharmacovigilance, and enhance patient trust in biosimilars.
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