On
October 23, twelve Senators sent a letter to Sen. Harry Reid (D-NV), asking the
Senate majority leader to "support the establishment of a responsible
pathway for the approval of follow-on biologic treatments, or 'biosimilars,'
that ensures patient safety and includes 12 years of data exclusivity." The letter, which was signed by Mark
Udall (D-CO), Christopher Bond (R-MO), Ben Nelson (D-NE), Kay Bailey Hutchinson
(R-TX), John Kerry (D-MA), Robert Bennett (R-UT), Thomas Carper (D-DE), Thad
Cochran (R-MS), Barbara Boxer (D-CA), Dianne Feinstein (D-CA), Paul Kirk, Jr.
(D-MA), and Mary Landrieu (D-LA), states that "[t]he bipartisan
vote this past summer by the Health, Education, Labor, and Pension (HELP)
Committee to provide 12 years of data exclusivity for innovator biotechnology
companies will help ensure the twin goals of making life-changing and
life-saving biologic treatments more accessible and affordable, while continuing
to foster the ongoing search for new cures and treatments."
The Senators contend that "lengthy
and costly research and development must be coupled with an adequate period of
data exclusivity for the innovator to ensure the future of new life-saving biotech
discoveries." Nothing that
"more than 150 patient organizations, research universities, venture
capital groups, and innovators have stated strongly that 12 years of data
exclusivity is crucial for ensuring continued growth and discovery in the
biotech industry," the Senators "urge [the majority leader], this
year, to support the enactment of 12 years of data exclusivity for innovator
biotechnology companies."
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