Mylan, Biocon Announce Positive CHMP Opinion For Ogivri, Biosimilar Trastuzumab

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche's Herceptin (trastuzumab).

The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in analytical testing, preclinical and clinical studies. Results demonstrated no clinically meaningful differences in quality, potency and safety; therefore, establishing biosimilarity to the reference product, Herceptin.

In addition, the Phase III clinical study (Heritage) demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity when compared to Herceptin in metastatic breast cancer patients, further reinforcing the highly similar nature of Ogivri.

The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by the end of 2018.

Ogivri is indicated for treatment of patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Under supervision of the relevant healthcare professional it can be prescribed as either monotherapy or in combination with other medicines dependent on the relevant diagnosis.