Samsung Bioepis’s Ontruzant (biosimilar, trastuzumab) Receives the Health Canada Approval for the Treatment of Breast & Gastric Cancer
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
