jäljitelmävalmisteet

Jäljitelmävalmisteet, known in English as generic drugs, are pharmaceutical products that are designed to be biologically equivalent to a brand-name drug, also referred to as the reference product. This means that the generic drug contains the same active pharmaceutical ingredient (API) in the same dosage strength, form, and route of administration as the brand-name drug. The primary goal of a generic drug is to offer a more affordable alternative to the original medication once the patent protection for the brand-name drug has expired.

The development and approval process for generic drugs in most regulatory systems, such as those in the European Union and the United States, requires manufacturers to demonstrate bioequivalence to the reference product. This involves conducting studies to show that the generic drug is absorbed into the bloodstream and reaches its target site of action at the same rate and extent as the brand-name drug. Minor differences in inactive ingredients, such as fillers, binders, or colorants, are permitted as long as they do not affect the safety, efficacy, or quality of the drug.

By providing identical therapeutic benefits at a lower cost, generic drugs play a significant role in healthcare systems by increasing access to essential medicines and reducing overall healthcare expenditures. Patients and healthcare providers can have confidence in the quality and effectiveness of generic medications due to the rigorous regulatory oversight and approval processes they undergo.