By
Donald Zuhn –-
Earlier this month, four Senators sent a letter to Senate majority leader Harry Reid
(D-NV) expressing their "strong support" for including an approval pathway
for biosimilars in any health care reform package brought to the Senate floor
for a vote. The Senators -- Orrin Hatch (R-UT), Barbara Mikulski (D-MD), Michael
Enzi (R-WY), and Kay Hagan (D-NC) -- noted in their letter that an amendment passed by the Senate
Health, Education, Labor, and Pensions (HELP) Committee and calling, in part,
for a 12-year data exclusivity period "received strong bipartisan
support when it was considered," and had been passed by the HELP Committee
by a 16-7 vote. Noting that
"[m]ore than 150 patient groups, research universities, local chambers of
commerce, venture capital groups, and innovators have expressed strongly that a
base 12 years of data exclusivity is crucial to ensure continued growth in the
biotechnology industry and future discoveries that will make a difference in
the lives of millions of patients," the Senators urged the majority leader
"to support the enactment of a pathway for the approval of biosimilars
with a base 12·year period of data exclusivity for innovator biotechnology
companies."
Comments