Samsung Bioepis’s Ontruzant (biosimilar, trastuzumab) Receives the Health Canada Approval for the Treatment of Breast & Gastric Cancer
- Health Canada has approved Ontruzant, a biosimilar referencing Herceptin (trastuzumab) for the treatment of adults with EBC, MBC, and MGC
- The approval was based on a comprehensive data package and totality of evidence including analytical, PK & clinical data along with pharmacology and toxicology data to evaluate Ontruzant (150/440mg vial) in patients with breast & gastric cancer. The results showed that Ontruzant & reference trastuzumab are highly similar with no clinical difference
- Ontruzant is the 5th biosimilar to be approved for use in Canada i.e., Brenzys (etanercept) in Aug 2016, Renflexis (infliximab) in Dec 2017, Hadlima (adalimumab) in May 2018, Aybintio (bevacizumab) in Nov 2021
Ref: Globe Newswire | Image: Samsung Bioepis
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