Organon Says European Medicines Agency (Ema) Validates Henlius And Organon Filings For Prolia And Xgeva (Denosumab) Biosimilar Candidate HlX14
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Organon announced that the European Medicines Agency (EMA) has validated the marketing authorization applications for HLX14, a biosimilar candidate for Prolia and Xgeva (denosumab). This biosimilar targets the treatment of osteoporosis, a condition affecting millions in Europe.
May 24, 2024 | 10:03 am
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Organon received EMA validation for HLX14, a biosimilar for Prolia and Xgeva, which could enhance its market position in the osteoporosis treatment segment in Europe.
The EMA validation is a crucial regulatory step that could lead to the approval and subsequent market entry of HLX14. This would potentially increase Organon's revenue and market share in the osteoporosis treatment market.
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