Biocon is to launch the world's first biosimilar of Roche’s blockbuster cancer drug Herceptin in about a fortnight for the Indian market.
The Bangalore-headquartered company's version of Herceptin (trastuzumab) will be called CANMab and be marketed for HER2-positive breast cancer, having been approved in November by the Drug Controller General of India. Biocon noted that 150,000 patients are diagnosed with breast cancer every year in India, of which nearly 25% are HER2 positive. However, "lack of affordable treatment options has limited the extent of HER2 testing," so the proportion of patients eligible for CANMab is probably higher.
The Biocon version has been priced 25% lower than branded Herceptin, coming in at 57,500 rupees (about $933) per 440mg vial. A smaller 150mg vial will be available for 19,500 rupees. The firm added that "unlike the product currently available in the market", both 150mg and 440mg formulations of CANMAb can be stored for a month "which is an important offering for patients in India, as it will ensure that there is no under dosing or wastage of drug which is quite common".
Global sales for Herceptin were around $6.40 billion in 2012 but hardly any of that came from India (just $21 million). Last year, the Indian government said it was looking at putting in place a compulsory license on the drug and Roche is not defending its patents on Herceptin there.
Indeed, the Swiss major's revenues from the blockbuster will only start to suffer when biosimilar versions of Herceptin hit the Europe markets (where there is a reasonably well-trodden biosimilar pathway) and Biocon and Mylan are just one of several candidates preparing to file here.