Biocon and Mylan launch Trastuzumab biosimilar Ogivri in US market

Bringing access to another biosimilar, biopharmaceutical-major Biocon has launched Trastuzumab biosimilar Ogivri in the US market. Ogivri, a biosimilar to Herceptin, has been co-developed by Biocon Biologics and Mylan and will be available in 150 mg and 420 mg strengths.

Ogivri will be launched at a competitive discount for customers to help ensure access and increase treatment options for patients, said the Bengaluru-based company.

“The US launch of Ogivri marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies,” said Christiane Hamacher, CEO, Biocon Biologics.

Biocon Biologics, a subsidiary of Biocon, has embarked on a journey to cross a revenue milestone of $1 billion and reach 5 million patients by FY22 and the launch of Trastuzumab biosimilar in the US markets would be one of the mileposts to achieve these targets, said pharma experts.

Ogivri is used to treat breast cancer and gastric cancer and Biocon has regulatory approval to sell it in more than 80 countries worldwide. It is the second biosimilar from the partnered portfolio of Biocon and Mylan being commercialised in the US. 

Last year, Biocon had launched Fulphila, a biosimilar Pegfilgrastim which is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. Biocon Biologics currently has a product pipeline of 28 molecules, including 11 partnered with Mylan, several with Sandoz and many being developed independently.

The company recently received a USFDA approvals for supplemental Biologics License Applications, expanding the manufacturing capability for Ogivri and Fulphila. “Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the US and global markets for both products,” said Biocon.

According to data, the US biosimilars market is projected to reach $17,696 million by 2026 and grow at a CAGR of over 50 per cent between 2019 and 2026. Multinational pharma giant Pfizer too received approval from FDA for Trazimera, a biosimilar referencing Herceptin in March this year and has plans to commercialise the product by February 2020.