Mary Therese PhelanChances are, the last time you asked your pharmacist to provide the generic version of your prescription medication, you weren’t thinking about complex research, intricate formulation development, or cutting-edge methodologies.
But all of those components are critical to bringing generics to the marketplace. To that end, as a result of a $5 million grant from the U.S. Food and Drug Administration (FDA), the University of Maryland School of Pharmacy (UMSOP) and University of Michigan College of Pharmacy (U-M) have established a joint Center for Research on Complex Generics (CRCG).
CRCG will increase access to safe and effective generic drugs through collaborative research, training, and exchange. The center also will facilitate information sharing between graduate students, postdoctoral fellows, those working in the industry, and faculty at both universities. It will be co-directed by James E. Polli, PhD, the Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at UMSOP, located at the University of Maryland, Baltimore (UMB) and Anna Schwendeman, PhD, associate professor of pharmaceutical sciences at U-M.
Generic drugs account for about 90 percent of prescriptions filled in the United States. However, some drug products are denoted to be complex products. Examples are products with complex active ingredients, complex formulations, complex routes of delivery, and complex drug-device combination products.
“Complex generic drugs are, in general, more difficult to develop due to formulation or mode of delivery, resulting in fewer complex generics on the market,” said Sally Choe, PhD, director of the Office of Generic Drugs (OGD) in the FDA’s Center for Drug Evaluation and Research. “By awarding this grant, our goal is to support research and development of these products so they can be made available to patients in a more timely way.”
Ultimately, Polli and Schwendeman hope the center will make complex analytical assays and pharmaceutical development expertise accessible to the generic industry and eventually lead to more rapid approval of high-quality and accessible generic products.
There are barriers to implementing new FDA guidance and achieving first-cycle approvals for complex generics.
“With at times a dearth of pre-existing knowledge about complex drug formulation and pharmacokinetics, the development and assessment of potential generic drugs is challenging,” Polli said. “The center aims to fill this gap by contributing to the ‘pre-competitive space’ for potential complex drugs.”
Funding from the grant will facilitate communication between OGD, the center, and generic industry stakeholders to better understand the needs for training, research and development, and implementation of new regulatory requirements; promote generic industry training through workshops, webinars and hands-on demonstration and engage fellows, students, and the public in complex generics research; and conduct collaborative research and technique development that facilitate complex generics.
“We wish to obtain input about which specific complex products, which analytical techniques, and which potential FDA guidance are needed, to facilitate the development of complex generics,” Polli said.
