Nature News has a story on biosimilar drugs, which differ from generics in their complexity.

Biosimilars differ from generic drugs because their active ingredients are huge molecules with intricate structures. Such molecules are nearly impossible to replicate in every detail — even in the hands of the original manufacturer, minute variations in production yield slight differences. Unlike the relatively simple construction of a small-molecule drug, making a biosimilar is more like placing a complicated family recipe in the hands of a new chef.

And even though the drug may still be costly, they are all the rage, according to the story.

(S)ome companies see biosimilars as a low-risk way to bolster dwindling drug pipelines. Biological drugs are expensive, and even with a 20-30% reduction in the original price, biosimilars can still pull in a huge profit. “Not a day goes by when you don’t read a press release saying some company is getting into biosimilars,” says Michael Malecki, head of the biosimilars group at Decision Resources, a market-research firm based in Burlington, Massachusetts

The story reports that the drugs have a “toehold” in Europe and are the subject of FDA hearing this week. Among those who testified yesterday was Graham Jones, associate director of Northeastern University’s Barnett Institute of Chemical and Biological Analysis.

In this NU story on biosimilars, Jones makes the case for oversight.

Obviously, we have a crisis looming in determining the composition of biological agents used as drugs," says Barnett associate director Graham Jones, professor and chair of chemistry and chemical biology…. “There’s a need for independent oversight and for good advice for would-be drug manufacturers. And the Food and Drug Administration wants technologies that can detect problems in the composition of drugs before they become problems in the clinic.”