+91 80 2808 2808

Biosimilar Trastuzumab Co-Developed by Biocon Receives Approval in the EU

  • Posted by: BIOCON

Bengaluru, India, December 19, 2018

Ogivri®, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. The European Commission has granted Marketing Authorization for Ogivri to our partner Mylan.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) 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 (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.

– Company Spokesperson

Author: BIOCON
Leaving the Biocon site!

You are now leaving the Biocon website for a Biocon affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

Agree >>