Media

Press Release

GPhA/FDA Fall Tech Conference Highlights Coming Biosimilar Market

Expense and Investment Required Will ‘Change the Face of Industry’

BETHESDA, MD., OCTOBER 20, 2010 – The new regulatory process being developed by the Food and Drug Administration (FDA) for approving biogeneric and biosimilar products eventually will enable industry to bring high quality, cost effective versions of biologic medicines to market with the levels of penetration now seen in the traditional pharmaceutical business, said Craig Wheeler, President & CEO of Cambridge, Massachusetts-based Momenta Pharmaceuticals Inc. Mr. Wheeler, who serves on the Executive Committee of the Generic Pharmaceutical Association (GPhA) Board of Directors, delivered the opening remarks at the 2010 GPhA/FDA Fall Technical Conference, which began today in Bethesda, Maryland.

“Follow-on biologics are becoming increasingly important to generic manufacturers, but the investment in technology required to bring these products to market will both add to the risk and change the economics required for industry to succeed,” Mr. Wheeler said. He noted that companies electing to compete in the biosimilar segment will need to invest in the characterization technologies, process engineering and clinical tools needed to demonstrate the safety and efficacy of these products. “This will change the face of our industry,” he said.

Mr. Wheeler also addressed security of the pharmaceutical supply chain and said that pedigree tracking is another challenge being address by industry. “It is clear that drug safety considerations require us to track and control our products, but defining how to do this is proving to be very complex as we wrestle with sometimes conflicting state regulations, competing technologies, and standardization,” he said. While it is critically important that we ensure the quality of our product across the entire distribution chain, “it also is important that we ensure cost effective tracking solutions that enable their use in the lower margin world of generic drugs,” he added.

“Sometimes our biggest challenges are our best opportunities,” Mr. Wheeler told the 600 attendees at the conference. He added that none of the critical issues can be successfully addressed by either industry or FDA alone, rather, there must be a partnership between companies and regulators. “We all share the common goal of advancing the availability of quality, affordable generics drugs.”
(The complete text of Mr. Wheeler’s address and other details of the GPhA/FDA Fall Technical Conference are available by calling 202.249.7100.)

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 75 percent of the prescriptions dispensed in the U.S. but consume just 22 percent of the total drug spending. Additional information is available at gphaonline.org.

-- 30 --

• More press releases
• Other resources in Biogenerics