---
title: "Mabwell passes Brazil ANVISA GMP inspection for denosumab biosimilars"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/295337739.md"
description: "Mabwell passed Brazil's ANVISA GMP on-site inspection for its denosumab biosimilars, 9MW0311 and 9MW0321. This marks the company's second PIC/S-member GMP clearance, following a prior success in Jordan. The certification supports regulatory filings in Brazil as part of broader denosumab applications submitted across eight countries."
datetime: "2026-08-10T00:00:17.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/295337739.md)
  - [en](https://longbridge.com/en/news/295337739.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/295337739.md)
generator: "portal-rs"
---

# Mabwell passes Brazil ANVISA GMP inspection for denosumab biosimilars

-   Mabwell passed ANVISA GMP on-site inspection for its denosumab biosimilars 9MW0311 (Prolia biosimilar) and 9MW0321 (Xgeva biosimilar). \* Certification marks its second PIC/S-member GMP clearance, following a prior inspection outcome in Jordan. \* Outcome supports regulatory filings in Brazil, part of denosumab applications submitted across eight countries. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mabwell (Shanghai) Bioscience Co. Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202608092000PR\_NEWS\_USPR\_\_\_\_\_CN21735) on August 10, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**