New Paper Looks At Debate On Generic Medicines Of Biological Origin

“Whether or not there is an adequate supply of generic biological drugs available will be crucial to ensuring the economic viability of health systems in both developing and developed countries.” So writes the South Centre – an intergovernmental organisation that helps developing countries to combine their efforts and expertise to promote their common interests in the international arena – in a newly published Policy Brief dedicated to the international debate on generic medicines of biological origin.

Whether or not there is an adequate supply of generic biological drugs available will be crucial to ensuring the economic viability of health systems

Authored by Germán Velásquez, special adviser on policy and health at the South Centre, the policy brief states that while the debate on generic medicines is not new, the difference today is that attacks levelled against biological generic products are couched in even more “technical” and abstruse language. “The high price of biological drugs stems mainly from the introduction of barriers to the entry of generics into the market,” writes Velásquez.

He also mentions a change in the pharmaceutical industry’s approach to price-setting, “whereby prices no longer reflect the true cost of research and development plus a reasonable margin,” as another reason to explain the high cost of such medicines. According to Velásquez, prices are based on the product’s supposed “value” to the pharmaceutical industry in terms of financial speculation, and not on its role in promoting public health.

Biological Drugs Increasingly Used

Made from active protein substances that are reproduced through biotechnological methods, biological drugs are increasingly used worldwide. From diabetes to cancer, hepatitis to haemophilia, arthritis to multiple sclerosis, they are used to treat several diseases.

“By contrast, most drugs in use 20 years ago were either plant-derived or chemically synthesized,” notes Velásquez. “According to industry forecasts, pharmaceutical sales are expected to grow annually by 6.3 per cent between 2016 and 2022, when they should total US$ 1.12 trillion in sales, with biological drugs making up 50 per cent of the market.”

The special adviser on policy and health insists on the fact that in any debate on generics, it should be made clear that what is at stake is not identical products but therapeutic equivalents: what matters to the patient “is whether or not a drug can prevent, cure or mitigate the effects of the illness.”

“No Reason Why Biological Products Cannot Be Reproduced”

Even though there are, according to Velásquez, differences between the reproduction of biological products and that of chemically synthesized ones, there is “no reason why biological products cannot be reproduced under a clear set of rules that protect patients while ensuring affordable access to all those who need them.”  Instead of biosimilars, interchangeable biosimilars or bioequivalents, why not simply opt for biological generics? asks Velásquez before concluding: “We hope that WHO will succeed in issuing clear guidelines prioritizing patient protection over the financial interests of pharmaceutical companies.”


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