FilingReader Intelligence

Henlius biosimilar nears EU approval for $7.5bn market

July 28, 2025 at 10:31 AM UTC•By FilingReader AI

Shanghai Henlius Biotech's HLX14, a biosimilar of Prolia and Xgeva, received a positive opinion from the European Medicines Agency's key committee, recommending approval.

The European Commission is expected to issue a final decision within two to three months. Global sales of denosumab injections were approximately $7.462bn in 2024.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

Primary Source Document

VOLUNTARY ANNOUNCEMENT - BIOSIMILAR OF DENOSUMAB HLX14 (RECOMBINANT ANTI-RANKL HUMAN MONOCLONAL ANTIBODY INJECTION) RECEIVED POSITIVE OPINION FROM THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OF THE EUROPEAN MEDICINES AGENCY (EMA)July 28, 2025 at 10:15 AM UTC

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