Addressing the issue of biosimilars only in terms of the benefits for the NHS in terms of savings is not enough. Not surprisingly, in a conference organized in Milan by the ASL Pavia, the topic was tackled from three different perspectives: clinical, scientific and industrial.
"Biosimilar drugs, like all biologicals, are obtained through the use of cell lines, therefore equality with the originator is to be completely excluded" he recalls Silvano Cella, clinical pharmacologist at the University of Milan. “It's easy to mimic a protein's primary sequence, minus the spatial configuration. Furthermore, each cell line inevitably introduces modifications into the molecules, such as deamidations, glycosylations or phosphorylations. In fact, the concept is one of similarity, not of equality. And a biosimilar, to be approved, must demonstrate comparable efficacy and safety compared to the originator drug».
As for the criticality "it is essentially constituted by the potential immunogenicity, determined by the dimensions of the biological molecules, which however unites the biosimilars to the originators".
Armando Genazzani, pharmacologist at the University of Eastern Piedmont, after highlighting how the productive changes of the various biologicals over the years are reflected in different chromatographic profiles, disputes an axiom on the appropriate use of biosimilars: «All the experts say that the replacement of therapy in the same patient should not be done because it is very dangerous. But a recent review highlighted the lack of data from trials or phase IV surveillance on safety issues due to switches between biopharmaceuticals.
"However, it should be reiterated that the current regulation guarantees the quality, efficacy and safety of the biosimilar to protect patients," he says. Francesco Colantuoni, vice president of Assogenerici «and that the registration process – in which clinicians, companies and patients are involved – is public and transparent. Furthermore, for each new drug, post-marketing monitoring is always foreseen and no biosimilar has so far been withdrawn from the market".
December 21, 2012 – DoctorNews
