Cheap biosimilars to come from India and China

Biosimilares/Novedades | Posted 21/10/2011 post-comment0 Post your comment

On 19-20 September 2011, the United Nations (UN) held a High-Level Meeting to develop a global strategy to fight non-communicable diseases, ‘principally cardiovascular diseases, cancers, chronic respiratory diseases and diabetes.’ It is only the second global health issue that the UN General Assembly has deemed urgent enough to call a meeting to discuss. Such diseases cause approximately two-thirds of all deaths.

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At stake is a desire to get modern treatment to poor people. The US always strongly defends patent rights, whereas the poorer nations argue that compulsory licences— allowed 10 years ago due to the AIDS epidemic—should be available to all countries, not only countries facing particular emergencies. The rich countries and companies were shamed into allowing firms such as India’s Cipla to formulate AIDS treatments at one dollar a day or less. In retrospect, the battle over AIDS medicines was a small skirmish compared with the one likely to erupt over cancer, diabetes and heart medicines. The AIDS drug market was never a major moneymaker for global drug giants, while cancer and diabetes drugs are central to the companies’ survival. For example, Roche earns US$19 billion annually, or half its annual drug sales, selling the biological cancer drugs Rituxan (rituximab), Avastin (bevacizumab) and Herceptin (trastuzumab).

India and China set to slash the price of biologicals
The biotech industry argues that biosimilars of complex biologicals cannot be produced easily like the traditional generics of small molecules. Unique and expensive studies are needed to prove that they work as advertised; interchangeable status at the pharmacy is hard to obtain. Costs will remain high.

But Cipla and a Chinese partner, BioMab, seem determined to disprove this. Interviewed shortly before the UN meeting, Cipla CEO Dr Yusuf Hamied said that they are together investing Euros 124 million to build plants in India and China to produce at least a dozen biotech medicines. Other Indian companies have also built such plants. Once testing is complete, Dr Hamied promises to sell the drugs at a third of their usual prices. In fact, ‘once we recover our costs, our prices will fall further’, he told The New York Times. ‘A lot further.’

What is best for the poor?
The biotech copycats are likely to stir sharp debate among advocates for the poor. While some UN officials insist that the developing world needs to get the classic blockbuster biologicals at a low cost before they can effectively fight cancer and other non-communicable diseases, others contend that the billions spent to treat AIDS have crowded out cheap and simple solutions to other afflictions of poverty, such as childhood diarrhoea.

Source: infojustice, The New York Times

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