The pharmaceutical industry is one of the emerging sectors in Malaysia. The products produced in Malaysia are divided into four categories: prescription drugs, over-the-counter (OTC) drugs, traditional medicines, and health and dietary supplements.
In Malaysia, the National Pharmaceutical Regulatory Agency (NPCB) is responsible for the supervision of generic medicines and the Pharmaceutical Services Division (PSD) is responsible for the quality, efficacy and safety of pharmaceuticals.
On January 4, 2024, NPCB updated the List of Approved Biosimilars, which provides the details of approved active substances to ensure the safety use of biosimilars. 15 active substances are added to the List: Adalimumab, Bevacizumab, Enoxaparin sodium, Erythropoietin (Epoetin Alfa), Etanercept, Filgrastim, Human Insulin, Infliximab, Insulin Aspart, Insulin Glargine, Pegfilgrastim, Rituximab, Somatropin, Teriparatide, and Trastuzumab. The List also specifies the product name, registration number, and its manufacturer. This measure may enhance the market competition and reduce the risk of using unqualified or harmful drugs.
NPCB will update the List to ensure the legitimate operation of the biosimilars. Details of this List can be seen from here:NPRA
