Mylan and Biocon's Trastuzumab Biosimilar Gains European Marketing Authorization

Mylan and Biocon have received final approval from the European Commission (EC) to market their trastuzumab biosimilar, Ogivri, referencing Herceptin. The drug earned authorization for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer as either monotherapy or combination therapy.

The companies announced the receipt of the marketing authorization, which applies to all 28 EU member states and the European Economic Area, this morning after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in October 2018.

The positive opinion was based on a data package that included analytical data as well as preclinical and clinical studies. The results from the studies found that there were no clinically meaningful differences between the reference trastuzumab and the biosimilar, and findings from the phase 3 HERITAGE clinical trial underscored the similarity of the 2 molecules.

In the HERITAGE trial, a multicenter, double-blind, randomized, parallel-group study is evaluating the efficacy and safety of the biosimilar in comparison with the reference trastuzumab in combination with a taxane as first-line therapy in patients with HER2-positive metastatic breast cancer, patients were randomized to receive either the biosimilar or the reference with a taxane every 2 weeks. After 24 weeks, patients with responding or stable disease were given trastuzumab as monotherapy. Patients were followed through 48 weeks for progression-free survival and 36 months for overall survival (OS). The primary end point was overall response rate.

Of the 230 patients treated with the biosimilar, 70% achieved a response, compared with 64% of the 228 treated with reference trastuzumab at week 24, with 1.3% of those in the biosimilar group and 0% of those in the reference group demonstrating complete response, and 68.3% of the biosimilar group and 64% of the reference group demonstrating partial response. As assessments are currently ongoing, OS will be calculated after either 36 months or 240 deaths.

Ogivri is also approved in the United States, where it received FDA authorization in December 2017. The drug is not yet marketed in the United States, however, and Mylan and Biocon have not yet announced a launch date for their product in either the US or European markets.