Research Article

Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment

Table 6

DCA approved biosimilars in Malaysia.

Product nameActive substanceTherapeutic areaAuthorization dateManufacturer/company name

SciTropinSomatropinGrowth disturbance in children and growth hormone deficiency in adultsAug. 2010Sandoz
BinocritEpoetin alfaRenal anemia, cancer, and predonation preparation for autologous and allogeneic blood transfusionMar. 2011Sandoz
ZarzioFilgrastimCancer, HSCT, and chronic neutropeniaMar. 2012Sandoz
NivestimFilgrastimCancer, HSCT, and chronic neutropeniaAug. 2013Hospira
InsugenRecombinant human insulinDiabetes mellitusJan. 2014Biocon

Source: DCA, 2014 [28].