Nephrology Forum in Cagliari. How safe are "copies" of biotech drugs? Bonanni: "Maximum attention to all stages of production"
Anna Maria Greco – Thu, 11/15/2012 – 19:54 – Il Giornale.it salute
Between 2014 and 2018, the patents of the 5 best-selling biological drugs expire, especially to fight tumors and rheumatoid arthritis. The door will be opened for a flood of so-called generics or "biosimilars" and the market will grow from the current $243 million to $3.7 billion, with costs decreasing by up to 25 percent.
This is good news for the national health system, where these non-traditional drugs represent 30 percent of the market. The growth is exponential, just think that in 2000 it was only 11 percent.
But what are the differences between traditional drugs, born from chemistry and those produced by biology, through complicated techniques of purification and genetic engineering on cells and DNA? Are the copies, in this case, just as effective and safe as the originals?
Fabrizio Bonanni, vice president of Amgen, a Californian company that was one of the pioneers in biotech research and production, spoke about this at the National Forum of Nephrology which was held in Cagliari these days. Never before in this sector, he said, are ethics important: "We have a moral contract with the patient."
At the congress, where the novelties of medical-scientific research on the treatment of nephrological diseases, which affect 5 million people in Italy, were presented, Bonanni explained: «Biological drugs are the most advanced ones, those of the future. But also the most difficult to "copy" while maintaining the same therapeutic value, because they are complex molecules. We work on very fragile drug proteins, subject to chemical attacks. The light, the air, minimal variations, the same size of the bubbles of a gas can cause damage and alterations».
Bonanni is a chemist and knows these problems well, being responsible for the production activities of all the company's plants around the world.
«For biotech - he said - the production process in all its phases is extremely delicate, from extraction to purification, up to the phases of packaging and transport. In this case, the process is the product and determines its quality».
Assobiotec (an association that brings together companies operating in the world of biotechnology) calls for ad hoc legislation for biosimilar drugs, whose active ingredients are not chemical but originate from living cells, different from that envisaged for equivalent drugs.
At the examination of the Senate Health Commission c&r
