The University of Michigan and University of Maryland will receive a five-year, $5 million FDA grant to establish the Center for Research on Complex Generics.

Funded by the FDA Office of Generic Drugs—the only known FDA grant of its kind—the center will focus on bringing complex generic drugs and drug products to market faster.
Project co-directors are Anna Schwendeman, associate professor at Michigan’s College of Pharmacy, and James Polli, professor at Maryland’s School of Pharmacy.

Nearly 90% of all filled prescriptions in the United States are generic products, and most common drugs are available in multiple generic versions. However, over time drug products have become more complex, and some newer analytical equipment, cutting-edge 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.

One such drug is AbbVie’s Lupron Depot, used to treat prostate cancer and endometriosis. Another is Gilead Science’s AmBisome, a liposomal injection to treat fungal infections. There are no approved generics for either drug in the U.S.

“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 scientist 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. Usually, generic companies submit an abbreviated new drug application to the FDA for approval to market a generic version. Generic companies aren’t required to repeat all safety and efficacy clinical trials for their version of the product, making development of generic versions cheaper. But they are required to show that their drug performs in the same manner as the original.

However, 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 said.

More information:

• Anna Schwendeman
• James Polli