Access to alternative biopharma-ceuticals in low- and middle-income countries

摘要

In recent years, biotherapeutics have gained a significant role in die management of life threatening diseases including cancers and diseases of the immune system. Biopharma-ceuticals, also known as biologicals, are mostly produced by genetic manipulations of living organisms. Medicines produced through recombinant DNA (rDNA) methods, and monoclonal antibodies, are the most common biophamiaceuticals currently on the market worldwide. Monoclonal antibodies are mostly rDNA-derived proteins or glycoproteins. From a regulatory perspective, their assessment is basically similar to that for rDNA biotherapeutics. Despite their acceptable efficacy in several severe diseases, many patients in low- and middle-income and even developed countries are not able to afford them due to the very high prices.