2/10/2005

The FDA conference next week will assess whether generic drugmakers have the ability to manufacture "follow-on" versions of expensive biologics. Generic drugmakers say the science of biopharmaceuticals has advanced to the point where it is possible to get lower-costing biologics on the market. But brand drugmaker trade associations, including the Biotechnology Industry Organization, argue it is much harder to reverse-engineer a biologic than it is a small molecule drug because of the complications inherent in trying to duplicate complicated and variable proteins that biologics contain.

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