Herceptin biosimilar set for Indian market
pharmafile | January 21, 2014 | News story | Research and Development, Sales and Marketing | Biocon, Herceptin, Roche, biosimilars, canmab
Biocon has said its generic version of Roche’s ageing breast cancer drug Herceptin will go on sale in India from February.
Bangalore-based Biocon has jointly developed a biosimilar version of Herceptin (trastuzumab) with its US partner Mylan under the name ‘Canmab’.
About 150,000 people are diagnosed with breast cancer every year in India, of which around a quarter are eligible for treatment with Canmab, Biocon said in a statement.
Roche said last year that it had decided against pursuing a patent application for Herceptin in India, a decision which has paved the way for generic drugmakers to produce cheaper copies.
The Swiss firm decided instead to set up a deal with Indian drugmaker Emcure Pharmaceuticals to sell what it calls an ‘off-brand’ version of the drug, known locally as Herclon, in an effort to save face.
Biocon’s drug is not a generic per se but known rather as a biosimilar as it still required some R&D testing before approval. This is because Herceptin is a biologic and cannot be as easily – or cheaply – copied as other medicines can like statins or antiplatelet drugs.
Global sales for Herceptin were around $6.4 billion in 2012, but only $21 million of that came from India, according to Biocon.
Herceptin received its first ever approval by the FDA in 1998 for the treatment of metastatic breast cancer, but will begin facing generic erosion in Europe this year and in the US from 2019. These threats will hit the firm far harder than any lost sales in India.
Price wars
Biocon’s Canmab will be much cheaper than the off-brand Herclon that Roche sells in India, which currently costs more than 15 times the per capita monthly income.
But according to analysis from Bloomberg Industries, the first copy made by a native firm may still leave the price out of reach for most people.
It says that trastuzumab will be priced at 25% less than Herclon, but this will still be an extremely high price for the average Indian worker.
Leena Menghaney, a lawyer who works with Indian patients seeking affordable access to the drug, said: “On paper it looks very nice [the drug’s cost], but when you actually start calculating, it’s a high price for treatment.”
Biocon will sell Canmab in two different dosage sizes: a 440-milligram vial has a maximum retail price of 57,500 rupees ($933), whilst a 150-milligram vial costs 19,500 rupees.
But in comparison Herclon has a maximum price of about 75,000 rupees for a 440-milligram vial, according to a person familiar with the matter quoted by Bloomberg.
Patent wars
India has some form when it comes to allowing cheaper versions of patented medicines onto its market.
In 2012 the country’s regulator issued the first ever compulsory license to domestic drugmaker Natco Pharma, which allowed it to sell the kidney and liver cancer drug Nexavar, even though it is still under patent by its manufacturer Bayer.
Herceptin’s active protein was discovered before India’s 1995 deal with the World Trade Organisation that was created to help protect drug patents. Roche applied for – and received – a patent in India for a different composition of the medicine.
But India’s Supreme Court, in a separate ruling on Novartis’s blockbuster cancer drug Glivec last year, made clear it would not grant new patents for improvements to old medicines unless change led to much improved therapeutic efficacy.
India’s government had been considering issuing a compulsory licence that would have over-ridden Roche’s patent and allowed other local companies to produce cheaper versions.
Ben Adams
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