105PA China-manufactured bevacizumab biosimilar, HLX04, matches bevacizumab sourced from China, USA and the European Union

Background: Barriers to becacizumab (Avastin^®) access involved not only treatment costs but lack of treatment guidelines and drug supplies across the USA, Europe and emergent market. The limit access to treatment resulted in reducing the number of planned bevacizumab cycle treatments with impact on patient quality-of-life and survival. HLX04, a proposed bevacizumab biosimilar, is required to demonstrate pharmacokinetics (PK) and safety bioequivalence in compared with reference product, attempting to address unmet medical needs in which bevacizumab is frequently used in metastatic colorectal cancer (mCRC).

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