Dear all,Back to the Top
I came to know that for 'Essentially similar drugs' BE/BA studies are
not required for registration in Brazil. I will be highly appreciated
if somebody can give some idea about whether the information is correct
and if yes, what is 'Essentially similar drugs' and most importantly
why BE/BA studies are not required for it ?
Dr. Nirav Gandhi
Dear Mr.Nirav,Back to the Top
I do not agree with you that the BE studies are not required for
essential similar products. Also, Brasilian guidelines clearly spells
the submission of the BE reports in the ANVISA approved centres for
similar product registrations. [except for products which can are
excempted from BE requirements by the FDA for e.g. parenterals, gases,
topical products with no systemic action etc.]
The essential similar drugs to the original product are those which
have the same qualitative and quantitative composition in-terms of the
active substance, have same pharmaceutical form and are bioequivalent
to that of the innovator's product [i.e. the original product]. The
definition itself suggests that bioequivalency is most critical for
such products and this provides the regulatory conclusion of
therapeutic equivalence for the generic applications.
regards,
kaushal prajapati
Torrent research centre
BHAT
Dear all,Back to the Top
I came to know that for 'Essentially similar drugs' BE/BA studies
are not required for registration in Brazil. I will be highly
appreciated if somebody can give some idea about whether the
information is correct and if yes, what is 'Essentially similar
drugs' and most importantly why BE/BA studies are not required for
it ?
Dr. Nirav Gandhi
Back to the Top
Dear Mr. Kaushal,
I think everybody knows about the general rule regarding the products
which are excempted from BE requirements by the FDA. If you see the
latest news from Pharmabiz, which suggests that you can register the
'similar drug' in Brazil without doing BE study and I think some of the
companies are doing the same thing. Kindly focus some light on it.
Dr. Nirav Gandhi
Back to the Top
Dear Dr.Gandhi,
I think one should give thought to the basic scientific ideology behind
the Essentially similar drugs and on the guidelines [published by
ANVISA at http://www.anvisa.gov.br/] available for the same, rather
than relying only on articles focussing/suggesting on the marketing
strategies opted by various companies for brasil registrations, which
was published recently in pharmabiz.
regards,
kaushal
Back to the Top
Dear Mr. Kaushal,
I have initiated this discussion after a very stringent search for the
regulations for Esssentially similar drugs and in most of the
guidelines including FDA suggest to conduct BE study for the same. I
think and you will also agree that regulatory country like Brazil
nowadays does not allow any marketing strategy to work for registration
purpose and I believe, usually Pharmabiz does not give any wrong
information. So I think we should find out the proper reason for that
or else we should ask ANVISA or Pharmabiz for the same.
Dr. Nirav Gandhi
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