Hertraz is a biosimilar to Roche’s Herceptin and is indicated for the treatment of HER2-positive metastatic breast cancer. The drug is available in 440mg and 150mg strengths.
The Drug Controller General of India has approved Hertraz after reviewing data provided by Mylan. Mylan, in support of this approval, has conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin.
These analytical methodologies confirmed the high degree of molecular similarity and biological activity of Hertraz.
Mylan has also conducted a multi-center clinical trial to demonstrate comparable safety and efficacy to the reference product.
Mylan has been developing trastuzumab in partnership with Biocon. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the EU and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for product in India.
Mylan CEO Heather Bresch noted the company is excited to offer Hertraz to the thousands of women in India suffering from metastatic breast cancer who are in need of a high quality, more affordable treatment option.
"The launch of Hertraz not only represents a significant milestone in our biosimilars development program with Biocon, but, more importantly, supports our mission to expand access to high quality medicine around the world and demonstrates our progress against one of Mylan’s key future growth drivers," Bresch added.