Importância dos biossimilares no Brasil

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To increase access to reliable/affordable medicines.

To enlarge the so called specialized health assistance projects.

To include new products/new protocols.

To balance the trade medicine deficit.

To foster local R&D aiming at innovation within Brasilian territory.

To decrease Brasilian chronic external dependency on biopharmaceutical.

+/- 60% of Government medicine expenditure are for finished imported medicines.

PUBLIC HEALTH

CHALLENGES/DILEMMA

Pharmaceutical trade deficit balance.

Deficit grew by 137% from 2004 to 2009.

Deficit superior to R$ 10 bi expected in 2011 (MS)

Fonte: Sindusfarma, com base em Sistema Alice/MDIC/Secex.Nota: Dados referem-se ao Cap. 30 NCM.

Biopharmaceutical market in Brasil is mainly financed by Health Ministry.

• SUS biopharmaceutical expenditures are significant and have steady growthin the last 5 year.

• In 2008 the amount was R$ 2,3 bi against R$ 513 mi in 2.003.

• The projected expenses may reach up to R$ 3,2 Bi in 2011.

Fonte: Ministério da Saúde (2009a).

Procurement in volume. Expenditure in value.

Biopharmaceutical.

Chemical products

If it is necessary to do it there...

Biosimilars/Bio generics/Biologicalwhat is new about it?

It is not about products. They are among us since more than 18 years ago!

Patent protection for several biopharmaceutical blockbusters will loose patent protection within 3 years.

Exemplos que demonstram o risco:

Genérico de Rituximab

Genérico de Pegasys

EPO

Source: H. Schellekens (2005) FDA/DIA Scientific Workshop on Follow-on Protein Pharmaceuticals

Genéricos de EPO

É uma avaliação seria, neutral,

consistente, validável e confiável?

Sem conflito de interesse?

ABSORBANCE

AUC in humans1 week

92 g.hr/ml

0.07

0.06

Migration time (minutes)

17.5 18 18.5 19 19.5 20 20.5 21

Protein Product - 1

ABSORBANCE

AUC in humans1 week

0.06

0.05

Migration time (minutes)

Protein Product - 2

64 g.hr/ml

17.5 18 18.5 19 19.5 20 20.5 21

ABSORBANCE

AUC in humans1 week

0.05

0.04

Migration time (minutes)

Protein Product - 3

56 g.hr/ml

17.5 18 18.5 19 19.5 20 20.5 21

Estes produtos são “diferentes” ?

Estes produtos são “iguais”?

● O que acontece com os inovadores?

● Reprodutibilidade?

● Modificações ao processo?

● São biossimilares de sim mesmos?

● Provas clínicas de eficácia e segurança para as variações de produto?

Species B2021 B2023 B2027 B2029 B2031 B2035 B2088 B2122 Change (%)

Peak 1 56.31 55.13 56.04 57.63 67.04 67.51 66.33 69.27 22

Peak 2 33.18 33.15 34.69 34.64 27.2 26.4 28.91 24.24 31

Peak 3 6.63 6.5 6.79 5.58 4.51 4.72 3.21 4.63 112

Peak 4 3.06 3.13 2.48 2.05 1.25 1.38 1.55 1.53 150

Peak 5 0.82 2.08 0 0 0 0 0 0.34 infinito

Mab batches (peak are expressed as percent total AUC)

Distribution of charge variants of Mab in ion-exchange chromatography

Antibody process shows production cultures performing at 70% of the previous campaign using the same cell line, process and raw materials

Nestes 18 anos de historia

tivemos problemas de eficácia

ou segurança

com bio-produtos de boa qualidade?

They are certainly not a big threat...

Whatever we name them:

Bio similar, Bio generic, Follow on Biological,

No new biological...

...on the contrary...

so...

Bigger demand for clinical trials, new and qualified jobs in different areas. (CROs, Clinical Labs., Analytical Centres...).

Better qualification for professionals in various area of knowledge and expertise.

Creation of new formal and direct highly qualified jobs.

Technology absorption of high skill level and added value.

Better trade balance for the health sector.

To improve access to biopharmaceutical products by increasing competition.

Biotechnology independency.

Incentive to local R&D.

...It is a new era of opportunities and benefits.

Please, do not be afraid or prejudiced against similar to biopharmaceutical product...

Pharma industry will survive...will certainly find new areas of opportunities. It always does.

?Therefore...

Such statement it is just not fair or even polite!

Same...

Please stop doing this...you are much better...

We do Research, Develop,

Manufacture and Market

Biopharmaceuticals our families can use.

Our public commitment...

Quis transmitir nesta meia hora

uma mensagem central

aparentemente obvia:

Analisar sempre os argumentos

criticamente,

cientificamente,

com neutralidade

e em profundidade

Aplicando os mesmos critérios

para mim e para os concorrentes

Muito obrigado pela paciência!!