In India, where a vial of Roche Holding AG (ROG)’s breast cancer medicine Herceptin costs more than 15 times the per capita monthly income, the first homegrown copy may still leave the price out of reach for most people.
Roche’s eight-year-old drug will face competition starting next month from a cheaper version made by Bangalore, India-based Biocon Ltd. (BIOS) with a U.S. partner, Mylan Inc. (MYL) The copy will be priced 25 percent less than Herceptin, Biocon said Jan. 18.
That list price, however, isn’t much different from what patients were already paying for an off-brand Herceptin that Roche has been selling in partnership with an Indian drugmaker since 2012. Activists have pushed for an even bigger discount, saying they’re hoping for the kind of ripple effect that resulted when competition among Indian generic-drug makers drove down prices for HIV medicines.
“On paper it looks very nice, but when you actually start calculating, it’s a high price for treatment,” said Leena Menghaney, a lawyer who works with Indian patients seeking affordable access to the drug.
The pricing shows that Roche may have avoided a bigger hit to its Herceptin sales in India by deciding last year to abandon the patent for the drug. Bayer AG in 2012 lost a battle to protect the Indian patent on its Nexavar kidney cancer medicine. The government awarded a so-called compulsory license to Natco Pharma Ltd. allowing the company to sell a Nexavar copy for 97 percent less than Bayer charges.
India’s effort to bring down the high price of medicines for cancer has angered drugmakers, who say the country is abusing international law, and that the effort ultimately will hurt patients by giving drugmakers less incentive to invest in research and development.
Biocon will sell its version of Herceptin, which it is calling Canmab, in two different dosage sizes. A 440-milligram vial has a maximum retail price of 57,500 rupees ($933), while a 150-milligram vial costs 19,500 rupees. Copies of biologic drugs such as Herceptin are known as biosimilars because, unlike generic versions of chemical drugs, they’re not exact copies.
Roche’s off-brand drug, called Herclon, by comparison, has a maximum price of about 75,000 rupees for a 440-milligram vial, according to Menghaney and a person familiar with the matter who asked not to be named because the pricing decisions are private. Widespread discounting cuts about 20,000 rupees off the price of Herclon, sold by Roche together with Indian drugmaker Emcure Pharmaceuticals Ltd., they said.
Biocon calculated its 25 percent discount based on the maximum price, a spokeswoman said.
Mylan Chief Executive Officer Heather Bresch declined to comment on pricing, saying at this month’s JPMorgan Chase & Co. health-care conference in San Francisco that the company will have a competitive product.
Roche wouldn’t disclose numbers of patients or sales for Herceptin in India, saying only that 15 percent to 20 percent of the women who could be helped by the drug get it. “Several thousand” patients took the drug in India last year, more than twice the number treated in 2012, Grotzky said.
Expanding treatment to more women is more complicated than just lowering the price, and requires better infrastructure and more knowledge of the disease, plus improving the availability and quality of testing to show whether breast cancer patients will benefit from Herceptin in the first place, he said.
Biocon estimated Herceptin sales in India at about $21 million in 2012, a fraction of the 5.89 billion Swiss francs ($6.47 billion) in revenue the drug generated that year for Roche around the world. More than 145,000 breast cancer patients are diagnosed in India each year, and about a quarter of patients are eligible for treatment with Herceptin or its biosimilar, Biocon said.
Though Herceptin keeps its patent protection in the U.S. until 2018, Roche abandoned the Indian patent last year, citing the intellectual property environment.
Menghaney’s group called on the government to intervene and for Biocon to drop the price to less than 5,000 rupees per vial. That would “expand the patient pool far beyond the borders of the country and bring relief to the millions of women in developing countries who are battling this disease,” she said in a separate e-mailed statement after Biocon’s announcement.
Even if the biosimilar is also discounted from its 57,500 maximum retail price, a course of treatment will probably cost at least 712,500 rupees, or about $11,600, an amount that’s out of reach for the majority of women in India, Menghaney said.
“It’s not enough” of a discount, said Homa Mansoor, a New Delhi-based doctor whose 34-year-old sister starts treatment today with Herclon, the off-brand version of the drug sold by Roche and Emcure.
Mansoor’s sister has two toddler-aged children; she discovered her breast cancer while nursing her then one-year-old daughter. Because her husband, a shopkeeper, makes about 8,000 rupees a month, her parents are selling property and cashing out retirement savings in order to pay for her treatment. Mansoor said she negotiated a 53,000 rupee price per vial of Herclon.
Now, she said, the family will check the price of the biosimilar at her sister’s dosage to try to decide whether it’s worth it to switch. Yet her sister is better off than most, Mansoor said, because she has relatives who can help her navigate the medical system.
“How difficult is this for every common man?” Mansoor said. “It’s just out of reach. If she relapses or something happens, what effect will it have on my parents? How are they going to bear it? I really don’t know.”
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