alkuperäisvalmiste
Alkuperäisvalmiste, meaning the original medicinal product, is the first authorized and marketed formulation of a medicine containing a given active substance. It serves as the reference product against which subsequently authorized medicines — notably generic medicines and biosimilars — are evaluated for quality, safety and efficacy. The original product typically results from the innovator company's research and development and is supported by clinical data submitted for marketing authorization. Through patent protection and data exclusivity, the original product often enjoys a period of market protection, after which other manufacturers may obtain authorization to market generics or biosimilars that demonstrate equivalence or high similarity to the reference product.
For a generic to be approved, regulatory authorities require evidence of pharmaceutical equivalence and bioequivalence to
In Finnish pharmaceutical regulation, alkuperäisvalmiste is the term used to distinguish the reference product from other