The Biosimilars Debate: Is it Over?
An interesting cell formation observed in this group of cells treated with progesterone and stained with filipin, which is a natually fluorescent antibiotic that binds solely to free cholesterol. Viewed via a phase contrast microscope.
Two months ago, I discussed possible federal legislation intended to balance the competing need for scientific and medical innovation with the costs to patients for biosimilars. So where does the debate stand now?
Current proposals couple a regulatory approval pathway for biosimilars with exclusivity periods for pioneer biologics. As part of its July 15, 2009 health reform bill, the Senate Health, Education, Labor, and Pensions (HELP) Committee adopted an amendment proposed by Senators Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) that provides for a 12-year exclusivity period for pioneer biologics. On July 31, despite protestations from Rep. chairman Henry A. Waxman (D-Calif.) that the amendment is “exactly the wrong way” to create a pathway for approval of biologics, the House Energy and Commerce Committee approved H.R. 3200, which also includes a 12-year exclusivity period.
On September 29, ten governors wrote a letter in support of the exclusivity period to House Speaker Nancy Pelosi (D-Calif.), House Minority Leader John Boehner (R-Ohio), Senate Majority Leader Harry Reid (D-Nev.), and Senate Minority Leader Mitch McConnell (R-Ky.), stating, “[i]nnovator companies must be provided with at least 12 years of non-patent data exclusivity to allow for recovery of their original investment and to ensure licensing payments to our research institutions.” Read more
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