Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Yara S. Medeiros
Prof. Farmacologia UFSC Mdica Endocrinologista
BIOSIMILAR
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SIMILAR
MAGISTRAL GENRICO
FITOTERGovt PICO
GENRICO SIMILAR
Fase Pr-Clnica
Fases Clnicas
RESERVA
MERCADO
Menos $$
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5. Bioequivalncia
GENRICO #n
GENRICO #1
GENRICO #5
Medicamento Referncia
GENRICO #4 GENRICO #3
GENRICO #2
Medicamentos Genricos
- lei 9787, 10.02.99
Tempo de transio no Congresso Nacional = 8 anos Objetivo: reduzir o preo ao consumidor e estimular a concorrncia no setor.
FDA
Http://www.fda.gov
CE
Http://www.eudra.org
BRASIL
www.anvisa.gov.br/medicamentos/bioeq uivalencia/index.asp (RDC 17/07 e RDC 134/03)
Greece Germany Italy France Spain Denmark UK United States Netherlands Norway Bulgaria Czech Rep. Hungary Croatia Poland Estonia Slovenia Lithuania Mali Egypt China Indonesia Thailand Tunisia Jordan Argentina South Africa
(7 - 20%)
(15 - 30%)
(24 - 66 %)
0 10 20 30 40 50 60 70
Consumo de Genricos
PAS Estados Unidos Alemanha Dinamarca Inglaterra % 55 60 90 58
20%
Mais 25 SM A Class
5%
nenhuma
78%
10-25 SM B Class
14%
30%-40%
53%
4-10 SM C Class
31%
50-65%
29%
50%
Acima de 65%
8%
13,3 milhes
Mix 2008
8,1 milhes
Mix 2004
69%
54%
8% 23%
19%
27%
11,5 milhes
7,0 milhes
66% 38%
31%
15% 18%
31%
Genricos so oficialmente, no mnimo, 35% mais baratos que os medicamentos de referncia para o consumidor pode chegar 50% mais
barato.
As regies com menor desenvolvimento scio econmico apresentam menor consumo de medicamentos, especialmente de Genricos .
Necessidade de
Sade Pblica
Clinical Equivalence of Generic and Brand-Name Drugs Used in cardiovascular Disease: a systematic review and metaanalysis.
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and metaanalysis
It was identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in:
7 of 7 RCTs (100%) of beta-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of alpha-blockers.
Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin.
JAMA. 2008 Dec 3;300(21):2514-26
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and metaanalysis
support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.
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Farmcias de Manipulao
Produo artesanal em escala industrial, sem os controles de qualidade do processo industrial
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Productos
Biolgicos
Bioequivalencia?
Obrigada!