The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on Ontruzant (traztuzumab) this week.
The committee recommended it be approved for the treatment of various breast and gastric cancers.
If the European Commission (EC) decided to follow the recommendation, Samsung Bioepis development partner MSD, known as Merck in the US and Canada, will commercialize the drug in European markets an agreement inked in February 2013.
Under the agreement Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing.
However, production will be carried out by third parties according to a Samsung spokesman who told us the firm’s strategy is to “use multiple contract manufacturing organizations, in order to ensure the reliable supply of our products.”
Ontruzant, like Roche’s originator product, is a monoclonal antibody.