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Review Calls for Path to Global Harmonization of Biosimilar Development Regulations

March 17th 2025

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

FDA approved omalizumab biosimilar | Image credit: Rafael Henrique - stock.adobe.com
FDA Approves First Omalizumab Biosimilar

March 7th 2025

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From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

March 6th 2025

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FDA Approves Third Pair of Denosumab Biosimilars

March 4th 2025

Biosimilars Regulatory Roundup: February 2025
Biosimilars Regulatory Roundup: February 2025

March 1st 2025

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