The drug, Canmab, was co-developed in a joint venture between Biocon and Mylan, approved in December, and is set to be available at the beginning of next month for the treatment of HER2-positive metastatic breast cancer in India.
In a release this week, Biocon set out its pricing for the drug, manufactured from its Bangalore biologics facility, saying it would be sold at around 25% less than Roche’s reference product.
“Biocon intends to make a significant difference in the treatment paradigm for HER2-positive breast cancer in India by enhancing access to more affordable treatment with Canmab,” said managing Director Kiran Mazumdar-Shaw.
However, the firm has come under some criticism from one patient and public interest group, The Campaign for Affordable Trastuzumab, for not providing a suitably priced alternative to Hereceptin.
“A quick back-of-the-envelope calculation reveals that the introduction of the bio-similar will have little or no impact in terms of expanded access,” the group said in a statement yesterday. “Many Roche dealers already offer discounts to ‘steady customers’” and “Biocon’s price for the biosimilar is not significantly lower than what is available from Roche today.”
In an official statement sent to Biopharma-Reporter.com, Biocon said in India the current product price of Roche’s reference product is approximately one third of that in Europe and the US, and Canmab, at 25% less than Herceptin, “is a small fraction of global trastuzumab prices.”
Furthermore the company said it expected trade discounts, as alluded to by The Campaign for Affordable Trastuzumab, to equally apply to Canmab, pushing the price down further.
Continuing, the firm said: “Developing a quality biosimilar monoclonal antibody requires high technical skills, significant investments in clinical development and manufacturing and long gestation periods.”
“As a result, the cost to develop a biosimilar for global markets has been estimated at $75 – $250 Million. This is in stark contrast to the estimated $2-$3 Million required to develop the much simpler, traditional non-biologic generics.”
Furthermore, the firm justified the price due to “the investment required for a complex biologics manufacturing facility,” as well as tests demonstrating the drug’s biosimilarity and ongoing global clinical studies.
2012 sales of Herceptin in India stood at $21m (€15.5m), according to Biocon, a small percentage of the $6.4bn worldwide revenues.
Last week, the South Korean Ministry of Food and Drug Safety (MFDS) approved Celltrion’s version of Herceptin, Herzuma for use in South Korea.