Zirabev as a representative of the largest family of biosimilars in oncology
Summary. Biological drugs account for a large share of «pharmaceutical» costs in oncology, approximately half according to some estimates [1]. To meet existing needs and facilitate access to new treatment methods, subsequent versions of biological drugs are being developed, which may enter the market after the patent protection of the originals expires. Compared to reference drugs, biosimilars are usually cheaper and more accessible; therefore, they have the potential to significantly reduce healthcare costs. Bevacizumab, a monoclonal antibody, is the first drug that effectively uses the vascular endothelial growth factor (VEGF) molecular signaling pathway and its receptor (VEGF-R) as a pharmacological target. The great clinical potential of this drug is the basis for large-scale research work and expanding the scope of its use in the EU and the USA [2]. Evidence of the successful implementation of research results is the number of approved biosimilars of bevacizumab — 9, the largest in the EU among drugs used in oncology [3]. At the same time, the position of the European regulator is that after approval, biosimilars are interchangeable with their original drug and with each other, with the extrapolation of all indications for medical use without additional clinical trials [4]. This approach does not mean lowering the bar of regulatory requirements, because it is based on a special emphasis on the analytical part of the dossier, which requires the accumulation of significant efforts and experience from the applicants — often they are reputable innovative pharmaceutical companies. Such as Pfizer, which in 2019 received marketing authorization in the EU for the drug bevacizumab Zirabev® with the extrapolation of all indications of the reference preparation Avastin.
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