Mylan and Biocon are planning to file their biosimilar version of Roche’s widely-used breast cancer therapy Herceptin in light of positive clinical data reported at the ASCO meeting in Chicago.
The results of the phase III HERITAGE study showed that MYL-1401O is comparable in efficacy and safety to Herceptin (trastuzumab) in women with HER2-positive advanced breast cancer – raising the prospect of a cheaper alternative that could expand access to Roche’s $6.7bn blockbuster.
The 500-patient trial compared MYL-1401O to Herceptin – both given alongside a minimum of eight cycles of standard taxane-based chemotherapy – until the disease progressed. There were no significant differences between the groups on any of the clinical parameters assessed, according to the study’s investigators.
The objective response rates at 24 weeks were 69.6% with MYL-¬1401O compared to 64% with Herceptin, and the rates of serious adverse events were 36% and 38%, respectively.
“Trastuzumab has markedly improved survival of women with HER2-positive breast cancer, but many women around the world can’t benefit from trastuzumab due to its high cost,” said lead investigator Hope Rugo of the University of California, San Francisco.
“We hope that the introduction of biosimilars will expand patient access to this effective drug,” she added, telling a press briefing at ASCO that with many other biologics losing patent protection “biosimilars have the potential to significantly improve access to expensive agents”.
For now, biosimilars of Herceptin have only been launched in a couple of world markets – namely India (Biocon/Mylan’s candidate) and South Korea (Celltrion’s Herzuma) – but have yet to reach the US and other markets such as Europe and Japan.
EU patent protection for the branded drug was lost in 2014 and is due to expire in the US in 2019, and analysts at Sanford Bernstein have suggested Mylan and Biocon’s versions could be on the market by 2017 in Europe and in the US the following year.
Several other candidates are in development from the likes of Allergan/Amgen, Samsung Bioepis, Stada/Gedeon Richter, Pfizer/Hospira, Oncobiologics/Viropro, BioXpress Therapeutics and Biocad, amongst others.