Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.
The year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and Drug Administration (FDA). Nevertheless, there was no fall in the Biologics class, which was boosted through the authorization of 15 novel molecules, thus maintaining the figures achieved in previous years. Indeed, the decrease in approvals was only for the category of small molecules. Monoclonal antibodies (mAbs) continued to be the drug class with the most approvals, and cancer remained the most targeted disease, followed by autoimmune conditions, as in previous years. Interestingly, the FDA gave the green light to a remarkable number of bispecific Biologics (four), the highest number in recent years. Indeed, 2022 was another year without the approval of an antimicrobial Biologic, although important advancements were made in targeting new diseases, which are discussed herein. In this work, we only analyze the Biologics authorized in 2022. Furthermore, we also consider the orphan drugs authorized. We not only apply a quantitative analysis to this year’s harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes.
Objetivo: A barreira hematoencefálica (BHE) é um protetor natural do sistema nervoso central (SNC), mas também pode ser um fator limitante para fármacos devido a sua alta seletividade. Uma maior permeabilidade e menor seletividade da BHE não mostrou ser a resposta para melhorar os tratamentos medicamentosos de pacientes com doença de Alzheimer (DA) e outras demências, pois dados encontrados apontam que uma maior permeabilidade pode ser fator contribuinte para o avanço de demências. O presente trabalho busca trazer os últimos avanços no tratamento da DA e fomentar a discussão sobre tais tratamentos e avanços, abordando especificamente a BHE. Abordaremos os aspectos fisiológicos da BHE relacionando-os com os fármacos usados para o tratamento, abordando também as características dos fármacos que dificultam atravessar a BHE. Buscou-se realizar uma revisão principalmente da literatura estrangeira, trazendo os últimos avanços para o tratamento da DA, visto que existe uma quantidade maior de material sobre a BHE em material em inglês do que em português. Métodos: Foi realizada uma revisão da literatura utilizando os seguintes bancos de dados: PubMed, Scielo, Google acadêmico. O período de abrangência usado nas pesquisas foi entre 2005 e 2020. Buscamos revisar também ensaios clínicos atualmente registrados, que buscam estudar a BHE e a DA, na base de dados norte-americana clinicaltrials.gov. Revisamos também capítulos que abordavam a BHE de três livros, sendo um livro de fisiologia e dois livros de farmacologia. Conclusão: Conclui-se que a BHE não pode ficar de fora de pesquisas para DA e outras demências devido a sua extrema importância. Observou-se que a permeabilidade da BHE pode tanto beneficiar os pacientes futuramente se for mensurada e controlada, como pode também prejudicar e colaborar com o avanço das demências se não for totalmente compreendida. A perspectiva para o tratamento da DA sob este prisma da BHE mostrou-se positiva, devido a um aumento encontrado de novas abordagens para tratar, prevenir e compreender a DA.
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