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9MW0311

PharmaDeviceNews 9MW0311

Mabwell’s 9MW0311 and 9MW0321 denosumab biosimilars have passed an ANVISA GMP inspection in Brazil, advancing manufacturing readiness as the company pursues Brazilian marketing authorisation. Representative image.

Pharma & Biotech

Could Brazil become Mabwell’s next denosumab biosimilar market after ANVISA GMP inspection?

by Pallavi Madhiraju
August 10, 2026
0 Comments

Mabwell clears ANVISA GMP inspection for 9MW0311 and 9MW0321, advancing its denosumab biosimilar registration strategy in Brazil.

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clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. Johnson & Johnson medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

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