Mabwell will use the Brazil GMP win to accelerate denosumab filings across PIC/S markets.
Regulatory wins like this can open doors in large markets and strengthen a biosimilar company’s international credibility.
AI reasoning
Regulatory wins like this can open doors in large markets and strengthen a biosimilar company’s international credibility.
Curated summary
Mabwell said its subsidiary T-mab passed Brazil’s ANVISA GMP on-site inspection for denosumab biosimilars 9MW0311 and 9MW0321. The company says this is its second GMP certification from a PIC/S-member authority, after Jordan. Mabwell has already filed denosumab applications in eight countries, including Brazil, and has marketing approval in Pakistan.
Supporting evidence
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Source news
Mabwell clears Brazilian GMP inspection for denosumab biosimilars
The company says ANVISA passed its T-mab subsidiary on-site, marking a second PIC/S-member GMP certification and widening its global regulatory runway.
