Shanghai Henlius Biotech Inc. Receives Positive Opinion from EMA for Denosumab Biosimilar HLX14, Regulatory Reviews Ongoing in US and Canada
Reuters
Jul 28
<a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> Inc. Receives Positive Opinion from EMA for Denosumab Biosimilar HLX14, Regulatory Reviews Ongoing in US and Canada
Shanghai Henlius Biotech Inc. announced that its biosimilar of denosumab, HLX14, a recombinant anti-RANKL human monoclonal antibody injection, has received a positive opinion from the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency $(EMA)$. This positive opinion marks a significant step in the regulatory review process, potentially paving the way for the biosimilar's approval in the European market. The marketing authorization application $(MAA)$ for HLX14 had been validated by the EMA in May 2024. Additionally, the company's biologics license application $(BLA.SI)$ for HLX14 was validated by the U.S. Food and Drug Administration (FDA) in October 2024, and the new drug submissions (NDSs) for HLX14 were validated by Health Canada in September 2024. Shanghai Henlius Biotech Inc. had also entered into an agreement with Organon LLC, granting them exclusive rights to commercialize HLX14 globally, excluding mainland China, Hong Kong, Macau, and Taiwan.
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