Deficient Aseptic Filling And Freeze Drying Hamstring Sandoz’s US Herceptin
FDA Trastuzumab Filing First Submitted In December 2021; Parallel EMA Filing Also Pending
Sandoz spoke to Generics Bulletin in the wake of confirming a recent complete response letter for its partnered biosimilar Herceptin candidate in the US.
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FDA Begins Reviewing Henlius’ Trastuzumab
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
Sandoz EMA Trastuzumab Application Follows US Filing
Sandoz and EirGenix have followed their US filing for a biosimilar rival to Herceptin with a European filing for the EG12014 trastuzumab candidate.
Sandoz Files US Trastuzumab With EirGenix
Sandoz has filed the proposed trastuzumab biosimilar developed by partner EirGenix with the US FDA. If approved, the product will have to compete in an already busy market for Herceptin biosimilars.