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 the alkuperäisvalmiste, ensuring a similar therapeutic effect and safety profile when used under the same conditions. The original and its generics share the same active substance and dosage form, but may differ in excipients, packaging or price. Substitution policies vary by country and may depend on physician and patient considerations.

In Finnish pharmaceutical regulation, alkuperäisvalmiste is the term used to distinguish the reference product from other authorized medicines and to anchor regulatory assessments for generics and biosimilars.