Brazil to designate medicamentos similares as interchangeable

Home/Policies & Legislation | Posted 24/01/2014 post-comment3 Post your comment

Medicamentos similares (similar medicines) may soon be substituted with the reference drug in Brazil, under the latest initiative launched by the country’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA].

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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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Source: ANVISA

comment icon Comments (3)
Post your comment
Posted 19/02/2014 by Jessica
Response to: Medicamentos Similares

Dear Luciano Lobo,
Thank you for bringing this information to our attention. The article has now been updated accordingly.
Kind regards,

Posted 28/01/2014 by PharmaHealthIQ
Not much clarity

I am still confused. So far ANVISA was not allowing interchangeability of small molecule originator with their generics? Any clarity on the terms 'similares' used here will be helpful

Posted 24/01/2014 by Luciano Lobo
Medicamentos Similares

Dear sirs
The new regulatory act from Brazilian National Surveillance Agency - Anvisa regarding brand generic medicines (similares) is related to innovator products produced by chemistry sinthesis and NOT biologicals! They intend to standardize the market the interchangeability with bioequivalent drugs (similar and generics) and reference products. Could you please inform your subscribers?

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