Biocon one step closer to Europe nod for biosimilar of breast cancer drug

Firm obtains positive opinion on approval of Ogivri, a biosimilar to Roche's Herceptin (trastuzumab); final decision by year-end

Biopharma major Biocon and partner Mylan announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri.

The CHMP opinion for the drug, a biosimilar to Roche’s Herceptin (trastuzumab), will now be considered by the European Commission and the decision on approval is expected by year-end. Herceptin had brand sales of $1.9 billion in Europe for the 12 months ended July 31, according to IQVIA.

Ogivri was approved by the US Food and Drug Administration (USFDA) in 2017 and is the first FDA-approved biosimilar for Herceptin in the US. 

Biocon Chief Executive Officer & Joint Managing Director, Arun Chandavarkar, said, “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.”

Ogivri is indicated for treatment of patients with HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. 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.