FDA Begins Reviewing Henlius’ Trastuzumab
The Oncology Biosimilar Is Already Approved In China And The EU
The US FDA has accepted a BLA for Henlius’ trastuzumab biosimilar candidate HLX02, marking another step in the Chinese company’s push for the US oncology market
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Organon has agreed to pay an upfront price of $73m plus potentially a further $30m in milestone payments this year alone for the rights to Shanghai Henlius Biotech’s HLX14 denosumab and HLX11 pertuzumab biosimilar candidates outside China. The deal also offers Organon an option to negotiate with Henlius for rights to its ipilimumab biosimilar.