Biologic product is defined by NPRA as product whose active substance is made by or derived from a living organism (plant, human, animal or microorganism) and may be produced by biotechnology methods and other cutting-edge technologies. This product imitates natural biological substances in our bodies such as hormones, enzymes or antibodies. This can range from vaccines, blood products, monoclonal antibodies, recombinant proteins and cell gene therapy products.
Biosimilar product is defined by NPRA as a new biological medicinal product developed to be similar in terms of quality, safety and efficacy to an already registered, well established, medicinal product.
Biologic and Biosimilar products are essentially larger and highly complex moleculer entities manufactured from living cell. Thus, the requirement of registration is a lot more complex and detailed then the common pharmaceutical product registration.
Having a reference country registration would greatly aid a Biologic and Biosimilar product registration in Malaysia BUT, it’s not mandatory. So long as the product dossier meets NPRA’s Guidelines (which are largely based on EMEA’s Guideline for Biosimilar & Similar Biological Medicinal Products), registration can be obtained.
NVS will evaluate the biologic and biosimilar product dossier akin to how the NPRA’s biologic team would be evaluating it.