The need to guarantee a new regulatory category for ‘value-added medicines’ has been proposed by the Asociación Española de Medicamentos Genéricos (AESEG), the Spanish trade group representing generic and biosimilar medicine manufacturers.
These drugs are listed as previously-authorized medicines being repositioned in different indications, new formulations and complex combinations.
As well as coming up with a clear and agreed definition of what they are, there is a need to introduce a process for fixing prices of these drugs that is transparent and understood by all involved, according to AESEG’s proposals, which underline the need for incentives for drugmakers and simplified regulation.
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