European Commission okays Mylan, Biocon’s biosimilar of cancer drug

Biocon 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," Biocon 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.

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.