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| Format: | Artículo científico |
| Langue: | en |
| Publié: |
Medical Education Cooperation with Cuba
2017
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| Accès en ligne: | https://www.redalyc.org/articulo.oa?id=437553387004 |
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Table des matières:
- Biosimilars and the Real World Nuris Ledón Naranjo Agustín Lage Dávila Medicina Cuba biologics biosimilars legislation social control Biotechnology has changed the pharmacopeia. It is expected thatin the nextfive years, 50% of biological products will originate frombiotechnology. Yet, treatments based on effective, costly biopharma-ceuticals for prolonged use hamper the goals of ensuring universaltherapeutic coverage and access to the best treatments. This conflictsurfaced 30 years ago with synthetic drugs, and the solution was tocreate generics once the developers’ patents expired. Biosimilars arenot generics, strictly speaking, as it is impossible to guarantee thatthey are molecularly identical to the original product; nor are they com-pletely new products, as they rely on a great deal of prior work done byother scientists. National strategies are needed to ensure the broadestpossible coverage in the best interests of the population. The key toa strategy to ensure access to the best treatment available lies in theconcept of “totality of evidence,” which includes all information abouta given molecular structure and its mechanism of action; safety andefficacy information from thefirst clinical trials; and monitoring datafrom products’ use in medical practice. A strategy of broad biologicaland molecular categorization plus intense pharmacovigilance wouldreduce development costs, the main barrier to widespread access. 2017 artículo científico 1555-7960 https://www.redalyc.org/articulo.oa?id=437553387004 en http://www.redalyc.org/revista.oa?id=4375 MEDICC Review application/pdf Medical Education Cooperation with Cuba MEDICC Review (Estados Unidos de América) Num.4 Vol.19