ROME – When asked whether biosimilars, i.e. the genetic versions of biotech drugs, can be the same as the "designer" molecule as happens with equivalent drugs, 3 out of 10 oncologists are unable to answer and 2 out of 10 think, wrongly, that there is identity with the parent molecule. It is the result, presented in Rome during a conference held at the Regina Elena Institute, of a survey carried out by the Aiom Foundation (medical oncology) on 700 Italian specialists. A delicate topic, which now concerns 40 percent of the drugs used in oncology: when patents expire, attempts are made to reproduce biotech molecules but the copies are not always the same as the model. «Biosimilars are not like their equivalents - explains Francesco Cognetti of the Regina Elena in Rome - France and Spain have prohibited the automatic replacement of a biological drug with a biosimilar on the basis of the fact that copying and synthesizing therapeutic proteins starting from living material is not how to copy acetylsalicylic acid: recently the EMEA denied authorization to the biosimilar of interferon alfa 2a». So far, two biosimilars (somatotropin and Epo) have been approved in Europe, but only in some countries: but will Italian health authorities also be able to order these molecules? The Tar, December 2007, says no.
Medical Courier of 05/06/2008 N. 17 29 MAY 2008
