U-M’s New Generic Drug Research Center to Speed Medicine to Patients

The University of Michigan in Ann Arbor will receive a $5 million grant to establish the Center for Research on Complex Generics, which will focus on bringing complex generic drugs and drug products to market faster.
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U-M is helping to establish the Center for Research on Complex Generics to help bring generic drugs to market faster. // Stock photo

The University of Michigan in Ann Arbor will receive a $5 million grant to establish the Center for Research on Complex Generics, which will focus on bringing complex generic drugs and drug products to market faster.

The funds, which were granted to U-M and the University of Maryland as part of a joint project, were awarded by the Food and Drug Administration Office of Generic Drugs and are the only known FDA grant of its kind.

Anna Schwendeman, associate professor at U-M’s College of Pharmacy, and James Polli, professor at Maryland’s School of Pharmacy, are co-directors of the project.

Nearly 90 percent of all filled prescriptions in the U.S. are generic products, and most common drugs are available in multiple generic versions. Over time, however, drug products have become more complex, and some newer analytical equipment, methodologies, software, and in-silico models are not readily available to the generic industry. Some of these products are starting to come off patent but are too complex to manufacture in generic form.

For example, AbbVie’s Lubprom Depot, used to treat prostate cancer and endometriosis, and Gilead Science’s AmBisome, an injection to treat fungal infections, have no generic equivalents.

“It is easy to make simple generic tablets and solutions, but complex products like metered inhalers, transdermal patches, creams, polymer implants (Lupron Depot) or liposomes (Doxil, AmBisome) are very difficult for generic companies to develop and get FDA approval to market,” the proposal states. “The way the products are manufactured often impacts their efficacy and safety, so it is hard to make effective copycat products.”

The center will provide training for the generic industry, collaborate on research with the generic industry and the FDA, and establish a visiting science program to host scientists from the Office of Generic Drugs and the generic industry.

Once a patent expires, generic versions of the brand name drug can be marketed, and these drugs are usually much less expensive than brand names. Generic companies usually submit an abbreviated new drug application to the FDA for approval to market a generic version.

Generic companies are not required to repeat all safety and efficacy clinical trials for their version of the product, making development of generic versions cheaper. They are required to show that their drug performs in the same manner as the original.

For complex products, the applications are often rejected during the first review cycle, which increases the cost of product development. The education and research efforts of the center aim to reverse this trend, increase first-cycle approval, and improve patient access to safe, effective, and affordable medications, Schwendeman says.

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