Health Canada approves Ontruzant biosimilar to treat breast cancer and gastric cancer.- Samsung Bioepis.
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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins