Mabwell passes Brazilian GMP inspection for denosumab

Mabwell, a biopharmaceutical company based in China, has recently passed a crucial inspection conducted by Brazil's Health Regulatory Agency, ANVISA. This inspection validates the quality management system of Mabwell's wholly-owned subsidiary, T-mab, which specializes in producing biosimilars of denosumab drugs, specifically 9MW0311 (Prolia® biosimilar) and 9MW0321 (Xgeva® biosimilar).

This achievement marks Mabwell's second GMP certification from a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), after a successful inspection in Jordan. Brazil, being the largest economy in Latin America and a member of the BRICS group, boasts the biggest pharmaceutical market in the region. ANVISA, as a PIC/S member, is renowned for its adherence to stringent GMP standards, aligning with International Council for Harmonisation (ICH) and World Health Organization (WHO) guidelines.

Passing this inspection not only highlights Mabwell's commitment to maintaining high-quality standards but also opens doors to broader market access in PIC/S member countries. Mabwell had already submitted market authorization applications for its denosumab products in eight countries, including Brazil, and has already obtained marketing approval in Pakistan.