16:37 Oct 3, 2011 

thank you all for the feedback! very good indeed!

15:27 Sep 3, 2011 

Actually, generics can and do have brands (we wouldn't speak of branded generics otherwise!). The issue here, in my very humble opinion, is the hazy definition of a "branded generic". All generics marketed in Brazil could be considered "branded generics", insofar as the brand is the manufacturer. We would thus have Medley-brand generics, Teuto-brand generics, EMS, Aché/Biosintética etc. The brand is the manufacturer. (Medley and EMS genéricos both have extremely distinctive brand identities, for instance: teal packaging which mimics that of the reference listed drug and plain royal blue packaging respectively).

What generics lack, by force of law, is a trade name (nome comercial). "Trade name" and "Brand name" are not synonymous with "brand" in this context... or shouldn't be.

I do agree that there is no literal translation in view of the differences in legislation... and I really do respect your opinion as a trained professional working in the pharmaceutical industry. You've prompted me to dig deeper, and I intend to do some further research into this.

08:45 Sep 3, 2011 

@ fvasconcellos:
"similares" have to go through the same testing as "genéricos" do in Brazil, since RDC 134, as you said so yourself. "Similares" are not interchangeable with reference drugs, no (I never said they were). I've found this from ims health (http://imshealth.com/deployedfiles/imshealth/Global/Content/... and they have Generics: other generics, unbranded generics, company branded generics, branded generics. You can't say sinvastatina (genérico) falls into the "branded generics" category, as it doesnt have a brand. The term "pharmaceutical equivalents" substitutes both "similares" and "genéricos" in the sentence above. I believe "branded generic" is the *equivalent* of "similar". That's my humble professional opinion. It's a complicated issue, as legislations are different in different countries and there's no literal translation. In my opinion, "Pharmaceutical equivalents" is ... for lack of a better word, too "generic" ;D

00:41 Sep 3, 2011 

Using the IMS Health definition of a "branded generic", both Medley "sinvastatina" (genérico) and Medley "Lipotex" (similar) would be considered branded generics, by simple virtue of the way meds are dispensed and marketed in Brazil. Unfortunately, the term "branded generic" does not suffice to distinguish genéricos/similares...

00:38 Sep 3, 2011 

With the 2003 regulations in place, "similares" must undergo *relative bioavailability* testing, but need not undergo full *bioequivalence* testing and are still not considered interchangeable with the reference listed drug, which, under Law 9787, is what makes or breaks a generic.

This has been a major point of contention among manufacturers recently, who have argued that relative bioavailability testing is enough to demonstrate bioequivalence. ANVISA disagrees. (I agree with you that it is not really a logical distinction, especially since RDC 134.)

23:17 Sep 2, 2011 

Bbbbbuuut..... You yourself say that generics can't have brands, and yet that contradicts the answer you posted. I can't understand how you arrived at your answer.

22:07 Sep 2, 2011 

Um exemplo para ficar mais claro. Todos os medicamentos baixo contêm o API sinvastatina:
Zocor da Merck --> Medicamento Referência, a Merck é a detentora da patente da sinvastatina e ela foi a primeira empresa a colocar a sinvastatina no mercado (Zocor é marca da Merck)

Sinvastatina da Biossintética --> Um dos medicamentos genéricos de sinvastatina no mercado brasileiro

Lipotex da Medley --> Um dos medicamentos similares de sinvastatina no mercado brasileiro (Lipotex é uma marca da Medley!)

21:53 Sep 2, 2011 

Please follow the link for Lei nº 9.787, de 10 de fevereiro de 1999 (http://www.anvisa.gov.br/legis/leis/9787_99.htm) that contains the definitions for "medicamento similar" and "medicamento genérico". Note that for "medicamento similar" it states "...devendo sempre ser identificado por nome comercial ou marca" . Generics, on the other hand, cannot have brands. It's a difficult concept for non-Pharmacists to grasp because, unfortunately, it is not logic and, in my opinion, it wasnt even suppose to exist such difference... but it does...

20:39 Sep 2, 2011 

Uruguay:
Interchangeable drug: A similar drug or pharmaceutical alternative which, by means of established procedures, has been demonstrated to be biologically and pharmaceutically equivalent to the reference drug.
Similar drug or pharmaceutical equivalent: A drug containing the same active ingredient and having the same concentration, pharmaceutical form, form of administration, dosage, and therapeutic indication, differing only in characteristics related to the size and form of the product, excipients, container, and labeling.
Pharmaceutical alternative: a product that contains the same chemical entity but that differs with regard to the salt, ester, or complex of this entity or with regard to the dosage form or potency.

Mexico:
Interchangeable generic drug: A specific pharmaceutical product containing the same drug or active substance and having the same pharmaceutical form, concentration or potency, and form of administration and the same or comparable pharmacopeial specifications, which, having passed the required regulatory tests, has demonstrated that its dissolution or its bioavailability profiles or other parameters, as the case may be, are equivalent to those of

20:36 Sep 2, 2011 

I recently did a translation for WHO on this subject. Below are some definitions under the laws of different countries that may help.

Brazil:
Generic drug: A drug similar to a reference or innovatorproduct that is intended to be interchangeable with the latter, usually produced after expiration or loss of patent protection or other exclusive rights, which is of proven efficacy, safety and quality and is identified by its Brazilian Common Name, or in the absence of such, the corresponding INN.
(Brazilian law does not define any other type of drug.)

Argentina:
Similar drug: A product that is formulated to contain therapeutically active substances and have pharmaceutical forms, forms of administration, dosages, indications and contraindications, precautions, warnings, adverse reactions, dissolution tests, and other correlative data that are similar to those of a product registered in the country or in countries listed the Annexes but which may differ in such characteristics such as size and form, excipients, shelf life, and primary container.