Το market access βιο-ομοειδών φαρμάκων στην Ελλάδα
Market access of biosimilars in Greece
KeywordsΒιο-ομοειδή ; Biosimilars ; Biosimilars in Greece ; Φαρμακευτικές εταιρείες ; Market access ; Βιολογικά ; Market access φαρμάκου
Biosimilars are pharmaceutical products that began to enter the international and domestic markets about 15 years ago, with the approval of the first drug occurring in the European Union in 2006. Biosimilars are exact analogs of biological drugs that, in most cases, although they are very popular among both healthcare providers and patients, they are expensive and require many years to produce and approve. In contrast, biosimilars using data from the clinical studies of biologic drugs are produced using much less financial resources and with commensurate effectiveness and safety, giving consumers more and more choices, reducing drug shortages and increasing healthy competition. Now, there are several legal and regulatory frameworks for the distribution of these products, especially in Europe. In many cases, their distribution is promoted not only by pharmaceutical companies, but also by the states themselves which determine the obligation of specific proportions for the administration of the drugs (eg 60% biosimilars / 40% biological). Certainly, it is becoming clear that research on biosimilars is in its early stages, and many more global clinical studies and trials are needed to ensure high levels of the products released into the market.