Biosimilar Drugs in Albania “current situation” |Biomedgrid

The use of biologicals is very important in the treatment of mild illnesses ranging from anaemia to life threatening cancers and neurological disorders. These biologics include products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins [1]. However, increasing use of these effective therapies is limited by their costs and accessibility. The expiry of patents of these products created new opportunities for the development of similar biologics (biosimilars) that could offer comparable effective and quality healthcare at an affordable cost [2-4]. To achieve comparable quality, efficacy and safety to their respective originator biologicals, strict compliance with appropriate science-based regulatory standards is essential to approve a biosimilar product [4].