Innovating and harmonising access and requirements amid the global regulatory challenges of biologics

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This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be essential and involve key stakeholders including regulatory authorities, the biopharmaceutical healthcare providers, patient advocacy groups and global harmonisation organisations.

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