Biosimilär

Biosimilär refers to a biological medicinal product that is highly similar to an already approved biological medicine, known as the reference product. Biosimilärs are not considered generic drugs; they are complex molecules that are manufactured using living organisms. The development of a biosimilär involves extensive analytical, non-clinical, and clinical studies to demonstrate its high degree of similarity to the reference product in terms of quality, biological activity, safety, and efficacy. The primary goal is to show that there are no clinically meaningful differences between the biosimilär and the reference product. Regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), have specific pathways for approving biosimilärs. The approval process ensures that biosimilärs meet the same rigorous standards of quality, safety, and efficacy as the original biological medicine. The introduction of biosimilärs aims to increase competition, potentially leading to lower healthcare costs and improved patient access to important biological therapies. Once approved, a biosimilär can be prescribed and used interchangeably with its reference product, though specific interchangeability policies may vary by region and national healthcare systems.