biosimilärs

Biosimilars are biological medicines that are highly similar to an already approved biological medicine, known as the reference product. They are not generic copies of small molecule drugs, but rather complex molecules produced from living organisms. The development and approval of biosimilars involve rigorous scientific assessment to demonstrate that they have no clinically meaningful differences in terms of safety, purity, and potency compared to the reference product.

The primary goal of biosimilars is to increase competition and patient access to important biological treatments. Because their development pathways are generally less extensive and costly than those for novel biologics, biosimilars are typically offered at a lower price. This cost reduction can lead to significant savings for healthcare systems and patients, allowing more people to benefit from advanced therapies for conditions such as cancer, autoimmune diseases, and diabetes.

Regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), have established specific pathways for the approval of biosimilars. These pathways require extensive analytical, non-clinical, and clinical data to prove biosimilarity. While biosimilars are highly similar to their reference products, minor differences in inactive ingredients are permissible as long as they do not affect safety or efficacy. The interchangeability of a biosimilar with its reference product is a separate regulatory designation that indicates a biosimilar can be substituted for the reference product by a pharmacist without the intervention of the prescribing healthcare provider.