Biocon,Mylan get EU approval for biosimilar of cancer drug

"Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. The European Commission has granted marketing authorisation for Ogivri to our partner Mylan," Biocon said in a regulatory filing.

New Delhi: Biotechnology major Biocon on Wednesday said the European Commission has approved and granted marketing authorisation to its biosimilar Ogivri, jointly-developed with Mylan, for the treatment of certain breast and stomach cancers.

"Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. The European Commission has granted marketing authorisation for Ogivri to our partner Mylan," the company said in a regulatory filing.

Biocon said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had previously issued a positive opinion recommending approval of Ogivri as a biosimilar to Roche's Herceptin (Trastuzumab) on October 18, 2018.

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

Also Read: USFDA completes Biocon Telangana plant inspection, no observations issued