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Medicamentos biossuperiores : caracterização, contextualização e perpectivas futuras

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In a time when the market for biologic drugs appears to become a fast-growing potential, with prospects of overcoming the winnings of smaller molecules, the regulators have increasingly crucial role in controlling the inputs of innovation. Thus, the biobetters are highlighted, above the biological reference that promises to shake the market. Biobetters owns a great potential in increasing the safety, efficacy and less immunogenicity. Allied to this, the prospect of developing other administration routes for proteins is extremely challenging, something that biosimilars can never achieve. A specific pathway approval for a sustainable growth, it will be a very positive aspect that has to be facilitated and assisted by the national authorities. Uncertainties are still quite evident in this field, but if this therapy overcomes all the expectations of acceptance, can be a great asset in a near future.

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Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2014

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Mestrado Integrado - 2014

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