Mabwell Secures Brazilian GMP Approval for Denosumab Biosimilars

The Brazilian inspection confirms that T-mab’s manufacturing processes meet the rigorous standards of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which are aligned with ICH and WHO requirements. This achievement follows a similar certification previously granted by authorities in Jordan, reinforcing the company's ability to navigate the complex regulatory landscapes of international markets.

As the largest economy in Latin America, Brazil represents a high-priority territory for the firm. Mabwell has already filed marketing authorization applications for its denosumab products across eight countries and currently holds approval in Pakistan. By demonstrating compliance with ANVISA’s stringent quality management benchmarks, the company strengthens its position to penetrate further PIC/S member markets, potentially accelerating the global rollout of its oncology-focused therapy portfolio.