South Centre: Clear Rules Needed On Biosimilars Equivalence To Help Market Entry, Lower Prices

As soon as 2022, biological drugs made from active protein substances are expected to make up 50 percent of the pharmaceutical market, as they are increasingly used to treat a number of illnesses such as diabetes, cancer and hepatitis. But with the high price of therapeutics and difficulty in producing biologically similar products, and with the originator products now coming off patent, regulation is of high importance, says a new report from the intergovernmental South Centre.

The International Debate on Generic Medicines of Biological Origin [pdf], a research paper from the South Centre authored by Germán Velásquez, calls for the World Health Organization “to issue clear guidelines prioritising patient protection over the financial interest of pharmaceutical companies.”

According to the paper, by 2020, half of biological drugs will go off patent, and there is an ongoing debate on how national regulatory authorities should get standards for the approval of “biosimilars.” The 2017 revised WHO List of Essential Medicines comprises 433 products, 11 of which are biological, the paper says.

“In any debate on the impossibility of producing ‘identical’ drugs, it should be made clear that what is at stake is not identical products but therapeutic equivalents,” according to the author. There is no reason why biological products cannot be reproduced under a clear set of rules that protect patients while ensuring affordable access, he said.