Biocon and Mylan N.V. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri 41 , 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 Ill 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.

Arun Chandavarkar, CEO and Joint Managing Director, Biocon said: "CHMP's positive opinion on Biocon and Mylan's biosimilar Trastuzumab is yet another endorsement of our ability to develop and manufacture complex biosimilars for the benefit of patients globally. This is the third molecule from our collaboration portfolio to receive positive opinion from the European CHMP. We shall continue to execute on our biosimilars strategy of expanding affordable access to high quality products targeting critical illnesses like cancer."

Shares of the company gained Rs 22.05, or 3.35%, to trade at Rs 680.50. The total volume of shares traded was 103,169 at the BSE (10.18 a.m., Monday).