BIO Seeking to Round Up Support for 12-Years Data Exclusivity

In advance of the Senate Health, Education, Labor, and Pensions Committee?s meeting to be held on Friday to consider amendments to the healthcare reform bill, including several amendments related to biosimilars, Biotechnology Industry Organization?s (BIO) President and CEO Jim Greenwood reaffirmed BIO?s support for a 12-year data exclusivity period for biologics.

In advance of the Senate Health, Education, Labor, and Pensions Committee’s meeting to be held on Friday to consider amendments to the healthcare reform bill, including several amendments related to biosimilars, Biotechnology Industry Organization’s (BIO) President and CEO Jim Greenwood reaffirmed BIO’s support for a 12-year data exclusivity period for biologics. Greenwood was speaking at a press conference on July 8, 2009.

According to Greenwood, “Now the base language in the [healthcare reform] bill is nine years data exclusivity plus three years additional as a possibility [for a supplemental application].” BIO continues to support 12 years of data exclusivity and is seeking support from senators before the Committee meeting. “We expect that this battle will flare up on Friday,” he said. “We have now until then to round up our votes.”

“There has been a flurry of activity around biosimilars in the last two weeks and the issue is far from resolved,” continued Greenwood. Recently, the AARP issued a statement indicating that the 12-year data exclusivity period was “unreasonable.” A letter was also sent by the Obama administration advocating for seven years of data exclusivity, which followed the FTC’s report indicating that there is no need for a 12- to 14-year data exclusivity period.

Earlier this year, two competing biosimilar bills were introduced by Rep. Henry Waxman (D–CA) and Rep. Anna G. Eshoo (D–CA) into the US House of Representatives for biosimilars. Under the Waxman bill, a new biologic product could receive a maximum of 5.5 years of market exclusivity before a biosimilar could be approved, whereas the Eshoo bill would provide for up to 14.5 years of market exclusivity for a new biologic product.

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