FDA Approvals of Biopharmaceuticals on the Rise
Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a press release about the report.
Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a press release about the report.
FDA approved 65 new biopharmaceuticals between 2000 and 2009, up from 39 approvals during the 1990s, and 13 in the 1980s. Of those new approvals overall, FDA approvals of recombinant protein products increased from 54% in the 1980s to 57% in the 2000s. In addition, the study showed that approvals of new biopharmaceuticals in the 2000s were more evenly distributed in six therapeutic categories, compared to those of the 1980s and 1990s.
At the same time, however, the average combined clinical and approval phase time for biopharmaceuticals rose to 95 months during the 2000s, up from 77 months in the 1990s. According to Reichert, that means drug manufacturers will need to “further streamline the development process to assure greater consistency across compounds and within disease areas.”
The full report is available on the Center’s website.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
