The agency released its proposal for establishing medicamentos similares as equivalent for public consultation on 16 January 2014. ANVISA is proposing that medicamentos similares should be interchangeable with their reference drugs. By interchangeable the agency means that the reference drug can be replaced by a medicamento similar that has presented equivalence studies for review and approval by ANVISA.

The change will mean that patients can gain the same benefits as are now available in Brazil for generic drugs. The measure will not require any change in the way prescriptions are written. At the pharmacy the patient will be able to choose between the reference drug and the medicamento similar, which will be identified as equivalent by presence of the acronym ‘EQ’ on the packaging.

At present in Brazil, when generics, which are interchangeable, enter the market they must be priced 35% lower than the reference product category. Health Minister Alexandre Padilha is proposing that the same be required for medicamentos similares, stating that the proposal for interchangeability ‘is an important step in the expansion policy of access to quality medicines to the population’.

ANVISA expects the measure to be introduced by the end of 2014.

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