Biotech Industry Readies for Possible Generic Competition

Congress is considering legislation that would give FDA the ability to approve generic versions of biotech drugs, and some of the industry's top-selling drugs are coming closer to losing patent protection, the San Francisco Chronicle reports.

However, some experts say the biotech industry might "lose less ground to generic manufactures than old-line pharmaceutical companies," according to the Chronicle.

Biotechs -- "celebrated for their innovative drive" -- are "trying to develop next-generation drugs that will supplant the original biotech medicines," and if they are successful, "generic versions of those older treatments could quickly lose their market to a new crop of brand-name drugs," the Chronicle reports.

The industry also might stall generic arrivals if Congress agrees to extend the no-competition period for biotech drugs to 14 years, as the industry has asked.

In addition, generic drug makers might shy away from producing generic biotech drugs because of the lengthy process required to develop production and win FDA approval, according to the Chronicle (Tansey, San Francisco Chronicle, 8/10).

In related news, NPR's "All Things Considered" on Thursday reported on generic biotech drug legislation. The segment includes comments from Donna Gosbee, a member of the National Multiple Sclerosis Society; Roger Williams, CEO of U.S. Pharmacopeia; and Tony Latrelle, vice president of MedImmune (Silberner, "All Things Considered," NPR, 8/9). Audio and a partial transcript of the segment are available online.