Researcher from University of Coimbra Describes Findings in Biosimilars (Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA).

A recent report from researchers at the University of Coimbra in Portugal discusses the development and approval process of biosimilar medicines. Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions. These medicines are very similar to already approved biological medicines and go through a less extensive clinical study process, making them more affordable and accessible to patients. However, due to the complexity and variability of these products, it is important to have strict controls to ensure their safety and efficacy. The report focuses on the regulatory framework and approval requirements set by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for biosimilar medicines. [Extracted from the article]