Modern cancer therapies should become affordable in poorer countries – knowledge


Everyone has to die at some point, Chaitali Haldar tried to console himself at the time. The social worker was 42 years old when cancer specialists discovered a particularly aggressive tumor in her right breast. The doctors at the All India Institute of Medical Sciences in New Delhi had told her ten years ago that there was a promising treatment for it, but she would have to pay ten times as much for the drug as she earned a month. For a single infusion bottle. She would need twelve of them for her therapy. Haldar, who had fought for the rights of victims of violence for years, knew that she would lose her own fight. She tried to come to terms with the fact that therapy was beyond her reach.

But Chaitali Haldar survived. Not only that her work colleagues collected the equivalent of almost 25,000 euros at the time to pay for their treatment. Above all, her misery left her boss at the time, Kalyani Menon-Sen, no longer in peace. “My colleague’s situation stunned me,” says the women’s rights activist. In 2013 Menon-Sen decided to launch a nationwide campaign for women with breast cancer in India: “It cannot be that only rich patients can afford modern cancer therapy.” In India, women usually have to pay for the treatment out of their own pocket.

Now finally, after eight years, there is hope for poor cancer patients. After a long struggle by both Indian and Colombian experts and activists, the World Health Organization (WHO) presented draft new guidelines a few weeks ago. They should make it easier to develop cheap copies of expensive drugs – and thus lower prices. “This is a big step,” says Huub Schellekens, professor emeritus for pharmaceutical biotechnology at the University of Utrecht, who also supported the design. Doctors call the cheap copies biosimilars. In contrast to generics, in which chemical active ingredients such as paracetamol are copied, the role models here are biological drugs. Antibodies, for example, that pharmaceutical companies produce in living cells using complicated biotechnological processes. The new WHO guidelines will enable more pharmaceutical companies to produce cheap copies of biological medicines for potentially life-saving treatments.

The Covid-19 pandemic has shown how big the differences are between rich and poor when it comes to access to medicines or vaccines. The gap is particularly wide when it comes to modern cancer treatments. The WHO estimates that in the developing countries alone, twice as many people will develop cancer in 2040 as there are today. In India, a woman is already diagnosed with breast cancer every four minutes, and a patient dies from it every 13 minutes. It is a cancer that is easy to treat today. In Germany, five years after diagnosis, almost 90 percent of patients are still alive. In India it is just 60 percent. The new regulations should now change that.

The WHO had already drawn up guidelines for biosimilars for the first time in 2009. “At that time it was not even clear what biosimilars exactly were, in many countries there were no regulations yet,” says Ivana Knezevic, head of the responsible working group for norms and standards of biological medicines at the WHO. The guidelines of the organization were intended to provide developing countries in particular with a basis for their own guidelines; in most cases, the specifications were taken directly into national legislation.

The previous rules play into the hands of large pharmaceutical companies in particular

However, the previous guidelines play into the hands of large pharmaceutical companies in particular. So far, a biosimilar has not only had to prove itself in laboratory tests. The drug copy must also go through clinical studies to prove its effectiveness in direct comparison with the original drug. A hurdle that small pharmaceutical companies usually cannot overcome: just buying the expensive original drug for the studies is unaffordable for many of them. “Developing the biosimilar for a modern antibody therapy in India costs between three and five million dollars,” says Hemanth Nandigala, managing director of the Indian pharmaceutical company Virchow Biotech. And clinical trials alone accounted for 70 percent of the total cost.

Therefore, some countries do not follow WHO guidelines. Colombia, for example, does not force its pharmaceutical companies to carry out large clinical comparative studies. India only introduced national guidelines on biosimilars in 2012. The consequence of this, however, is that the major manufacturers of the original drugs are particularly strong against the cheap competition. “That is very regrettable and does not throw a good light on these companies,” says Kiran Mazumdar Shaw, chairman of the Indian biosimilar company Biocon.

Suffragette Menon-Sen also experienced resistance from major companies when she started her nationwide breast cancer campaign. The first biosimilar of the active ingredient trastuzumab should finally come onto the Indian market, the antibody therapy that cancer patient Chaitali Haldar also received. The Indian company Biocon carried out comparative clinical studies, but not to the extent required by the WHO guidelines. The pharmaceutical company Roche promptly obtained an injunction against the company. Biocon was not allowed to refer to the Swiss company’s original product in advertising for its biosimilar. “It took three years before Biocon was allowed to market their product freely,” says lawyer KM Gopakumar from the Third World Network.

Can people in developing countries be fobbed off with drugs that have not been well tested?

Because the large clinical comparative studies are so expensive, biosimilars usually cost only 20 to 30 percent less than the original drug. This means that poor people are still excluded from cancer drugs such as trastuzumab in countries like India. “I sometimes feel guilty because other women still don’t have access to therapy,” says Chaitali Haldar, a cancer patient. To date, there are women in India who sell their home, land, or take out high-interest loans to pay for treatment. “Cancer takes everything away from them,” says Leena Menghaney from the organization Doctors Without Borders, which started the campaign with Menon-Sen. The lawyer from New Delhi explains that so that smaller pharmaceutical companies can also develop biosimilars, the high hurdles of the WHO guidelines would have to be lowered.

But is it permissible to lower biosimilar claims? Can people in developing countries be fobbed off with drugs that have not been well tested? About 7,000 kilometers from New Delhi, cancer doctor Paul Cornes sits in his office in Bristol and is very sure of his cause: “We don’t want lower standards for poor people.” Especially since he is concerned about the safety of these products, says Cornes, who is also involved in a working group at the European School of Oncology with access to innovative cancer therapies.

Biological medicines like antibodies come naturally in different variations. For example, one or the other tiny sugar chain sticks to the active ingredients. And so that the original drug and the biosimilar have the same effect and have the same side effects, they should have similar sugar chains. Pharmaceutical companies check this not only in laboratory tests, but also in comparative clinical studies. So far. “But the methods for protein analysis have improved dramatically. It is unlikely that we will overlook differences between the original drug and the biosimilar that could be relevant for the patient,” says the pharmacist Schellekens from Utrecht.

For example, an industry-related study from spring 2020 showed that in 95 percent of all biosimilars approved in the EU and the USA, the clinical comparative studies did not provide any information that went beyond the results of laboratory tests and small clinical tests. “Without clinical efficacy studies, we would not lower the claims, but instead abolish something that has no meaning for the evaluation anyway,” says Julie Maréchal, head of the department for Biosimilar Policy & Science at the Medicines for Europe organization, which protects the interests of biosimilar drugs and the generic industry in Europe. The British approval authority MHRA also came to this conclusion in an analysis in autumn 2020, and in May 2021 it presented new regulations that will largely dispense with clinical efficacy studies in the future.

The draft of the new WHO guidelines provides for a similar approach. Much more often than before, decisions should be made on a case-by-case basis as to which tests are actually necessary. “Today we understand better what is important for the development of biosimilars,” says Knezevic from the WHO. The experts will discuss the draft again in autumn and publish it in spring 2022. And thus contribute to ensuring that more people like Chaitali Haldar can afford modern cancer therapies.

Collaboration: Swagata Yadavar

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