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Health Canada approves Ontruzant biosimilar to treat breast cancer and gastric cancer.- Samsung Bioepis.

Read time: 1 mins

Published:5th Feb 2022

Samsung Bioepis Co. Ltd. announced that Health Canada has approved Ontruzant (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and metastatic gastric cancer (MGC).

Ontruzant is Samsung Bioepis’ fifth biosimilar approved for the use in Canada following Brenzys (etanercept) in August 2016, Renflexis (infliximab) in December 2017, Hadlima(adalimumab) in May 2018, Aybintio (bevacizumab) in November 2021. Ontrauzant will be commercialized in Canada by Organon.

The Health Canada approval was based on a comprehensive data package and totality of evidence which included analytical, pharmacokinetic (PK) and clinical data, as well as pharmacology and toxicology data. The data proved that Ontruzant and reference trastuzumab are highly similar with no clinically meaningful difference.

Condition: Breast Cancer + Gastric Cancer

Type: drug

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