Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021

Abstract

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.

Amphiphilic Polyampholytes for Fouling-Resistant and Easily Tunable Membranes

“…4,9,10 It is widely accepted that biological drugs, like proteins, peptides, antibody-drug conjugates, and nucleic acids, will play a major role in the future of pharmaceuticals. 11 These active pharmaceutical ingredients present complex molecular structures with varying sizes and net charges, making efficient separations difficult and costly. Therefore, it is important to develop robust membrane technologies that can keep up with the rapid pace of novel and complex molecules used as clinical therapeutics.…”

“…Biological separations are particularly challenging applications for membranes. The broad range of specific separations needed in these applications require tunable membranes that can be easily tailored to a given target application. ,, It is widely accepted that biological drugs, like proteins, peptides, antibody-drug conjugates, and nucleic acids, will play a major role in the future of pharmaceuticals . These active pharmaceutical ingredients present complex molecular structures with varying sizes and net charges, making efficient separations difficult and costly.…”

Polymerization‐induced self‐assembly for drug delivery: A critical appraisal

“…Nowadays, the therapeutic arsenal is much wider than the traditional small‐molecule, hydrophobic compounds. Sugars, proteins and nucleic acids (DNA and RNA) or complex combinations thereof are gaining popularity in the pharmaceutical field due to their high selectivity and low toxicity 143–146 . Typically, these biologics are not compatible with the stereotypical PISA as outlined in this Review.…”

Central carbon metabolite profiling reveals vector-associated differences in the recombinant protein production host Escherichia coli BL21

“…Concerning biopharmaceuticals, as of 2018, more than 300 protein-based drugs had been approved in Europe and United States, and almost a third of all pharmaceuticals in development were protein-based (Walsh, 2018). The market of protein-based biopharmaceuticals has only continued to grow, with numerous new drugs being approved each year (Martins et al, 2022), and global sales reaching $90.53 billion in 2020 (Sanchez-Trasviña et al, 2021).…”