New Herceptin biosimilar under EMA review

29 May 2019

Following in the footsteps of Celltrion (Kosdaq: 068270), Samsung Bioepis, Amgen (Nasdaq: AMGN) and others, Prestige BioPharma is making headway with its Herceptin (trastuzumab) biosimilar.

The Singapore-based company has had its marketing authorization application (MAA) approved by the European Medicines Agency (EMA), giving it the chance of reaching a major market with a copy of the Roche (ROG: SIX) drug, which is indicated for HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Prestige’s Phase I/III data on its HD201 candidate includes results showing exceptional biosimilarity to Herceptin in terms of clinical response and pharmacokinetics, and a comparable safety profile to the range previously observed in Herceptin biosimilar trials.

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