Sandoz Looks To Join EU Trastuzumab Party With CHMP Thumbs Up
Herwenda Biosimilar Referencing Herceptin In-Licensed From EirGenix In 2019
Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.
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With EirGenix about to start Phase III trials for its proposed biosimilar version of Perjeta, the Taiwanese developer says it is negotiating with global firms for rights to the pertuzumab candidate.
Sandoz spoke to Generics Bulletin in the wake of confirming a recent complete response letter for its partnered biosimilar Herceptin candidate in the US.
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.