06.25.07
Under legislation to be introduced in the U.S. Senate, makers of generic drugs would gain the right to market generic versions of biopharmaceutical medicines. The legislation would create a pathway for the FDA to approve generic treatments made through biotechnology.
According to analysts, competition from lower-cost generics may cut biopharmaceutical drug prices by a third. Generic companies are targeting drugs whose patents have already expired or are set to expire. Companies such as Barr Pharmaceuticals and Teva Pharmaceutical Industries have already made significant investments in acquisitions and facilities outside the U.S. for the technology to make generic versions of biopharmaceuticals.
The Senate proposal would require generic companies to conduct animal studies and at least one clinical trial in humans unless the FDA determines that these steps aren't necessary. The FDA also would have leeway to decide if a generic product could be substituted by a pharmacist for a prescribed brand-name drug.
European regulators allow approval of generic versions they refer to as biosimilars, however, these products are not recognized as identical to the original drugs. Novartis AG recently received support from a European panel to sell biogeneric versions of Johnson & Johnson's Eprex, an anemia drug sold in the U.S. as Procrit and as Amgen's Epogen.
The Senate health committee is expected to address the legislation on June 27.
According to analysts, competition from lower-cost generics may cut biopharmaceutical drug prices by a third. Generic companies are targeting drugs whose patents have already expired or are set to expire. Companies such as Barr Pharmaceuticals and Teva Pharmaceutical Industries have already made significant investments in acquisitions and facilities outside the U.S. for the technology to make generic versions of biopharmaceuticals.
The Senate proposal would require generic companies to conduct animal studies and at least one clinical trial in humans unless the FDA determines that these steps aren't necessary. The FDA also would have leeway to decide if a generic product could be substituted by a pharmacist for a prescribed brand-name drug.
European regulators allow approval of generic versions they refer to as biosimilars, however, these products are not recognized as identical to the original drugs. Novartis AG recently received support from a European panel to sell biogeneric versions of Johnson & Johnson's Eprex, an anemia drug sold in the U.S. as Procrit and as Amgen's Epogen.
The Senate health committee is expected to address the legislation on June 27.