Graham Jones, chair of the department of chemistry and chemical biology at Northeastern University, testified this week at a public hearing on “biosimilars” held by the U.S. Food and Drug Administration (FDA).
The hearing gathered input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009. The act was created to establish an approval pathway for biological products that are “highly similar” (biosimilar) to FDA-licensed biological drugs.
In March, Northeastern and the FDA signed a memorandum of understanding to advance methods of analysis for developing biosimilars. The agreement established a research collaboration, along with educational, training and outreach programs for members of the FDA, industry and academia in the areas of biotechnology and analytical chemistry.
Northeastern’s Center for Advanced Regulatory Analysis, housed within the Barnett Institute of Chemical and Biological Analysis, is leading several research projects, including the development of methods to assess the structural attributes, safety and efficacy of biological drugs.
“The hearing provided an ideal venue to showcase the power of analytical technology in resolving issues surrounding bioequivalence of branded and soon-to–be-introduced generic biopharmaceuticals,” said Jones. “Our Barnett Institute has pioneered the application of these methods for a number of decades, and it was gratifying to note the high level of interest in the testimony both from the regulators and biopharmaceutical industry.”
Sharing the podium with partners from Waters Corp., Jones noted that they were able to highlight cutting-edge advances by a number of Northeastern laboratories and researchers, including those of Barnett Institute director Barry Karger and associate professors of chemistry and chemical biology John Engen and Sunny Zhou.
“Given that health is one of the three great research challenges that Northeastern focuses on,” said Jones, “it is noteworthy that, through this hearing, we will have played a role in the formation of policy surrounding introduction of the new classes of biopharmaceuticals — the fastest growing segment of the $600 billion pharmaceutical industry.”
The hearing was a forum for researchers, doctors, drug companies and pharmacy groups to provide input on FDA implementation of the statute.
This fall, Northeastern introduced a professional master’s program in biopharmaceutical regulatory science.