( the first biogeneric was just approved...)Ten years later, Dolly is still making headlines

the first biogeneric was just approved last month in the United States by the Food and Drug Administration (FDA). This approval has opened a pandora's box of issues. Biopharmaceutical medications are some of the most expensive medicines on the market. Approving generic formulas, therefore, has the potential to put once inaccessible drugs within the reach of millions more people, but at what cost? At the Boston meeting, there will be an Open Forum on Sunday, June 18 from 8 a.m. to 5:15 p.m. in the Hynes Convention Center to discuss the various regulatory, scientific and ethical issues surrounding generic biopharmaceuticals, as well as:

• Why is the FDA slow to approve biogenerics?
• What are the risks of a biogeneric drug, like a human growth hormone, being used for the off-label purpose of anti-aging?
• With $20B of biotechnology-derived product losing patent protection over the next few years, how will the FDA handle this influx of legal and regulatory challenges?

National Biotechnology Conference

The AAPS National Biotechnology Conference is an annual event incorporating all aspects of pharmaceutical biotechnology and providing an open forum for discussion of industry topics. The conference will take place June 18?1 at the John B. Hynes Convention Center, Boston, Mass.

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Source:American Association of Pharmaceutical Scientists


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