Samsung Bioepis' Bevacizumab Is Cleared for Launch in Europe

The European Commission (EC) has given marketing approval for the bevacizumab biosimilar Aybintio, by Samsung Bioepis.

The Incheon, Republic of Korea—based company said the EC has indicated the drug for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer. These encompass all approved indications for the reference product, Avastin.

The company noted the drug was approved based on analytical, pharmacokinetic, and clinical data, as well as pharmacology and toxicology data, all of which demonstrated that Aybintio and the reference product are highly similar with no clinically meaningful differences.

“Approval of Aybintio provides another treatment option for patients with certain types of cancers, enabling wider access to those in need,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis, expressing pride in the drug authorization achievement.

Samsung Bioepis now has 5 biosimilars approved for use in Europe. These include Benepali (etanercept), Flixabi (infliximab), Ontruzant (trastuzumab), and Imraldi (adalimumab).

In June, Aybintio was recommended for approval by Europe's Committee for Medicinal Products for Human Use.