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Sen. Kennedy proposes 13.5 years of exclusivity for biotech drugs


WASHINGTON Long exclusivity periods for biotech drugs as part of legislation to allow a regulatory pathway for biosimilars got support from a key member of Congress this week.

Sen. Edward Kennedy, D-Mass., expressed support for 13.5 years of market exclusivity for biotech drugs before they face competition from biosimilars if a regulatory pathway is created, according to published reports. Kennedy favors nine years of exclusivity, plus four-and-a-half years if the Food and Drug Administration approves new uses of the drugs.

The biotech industry has pushed for 14 years of market exclusivity, while the generic drug industry has pushed for five years.

Earlier this year, Democratic Rep. Henry Waxman of California introduced a bill that would allow five years of market exclusivity for biotech drugs, while fellow California Democrat Rep. Anna Eshoo introduced a competing bill to allow 12 to 14 years. The White House has called for a seven-year exclusivity period.

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