“To amend the public health service act to establish a pathway for the licensure of biosimilar biologic products, to promote innovation in the life sciences.” Amendment No. 297.
The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee [1] voted Monday in favor of a proposal by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) to create a follow-on biologics (FOB) pathway that provides 12 years of data exclusivity for brand-name biologic drugs.
The measure passed 16 to 7, despite an earlier decree by the Obama administration that a seven-year exclusivity limit sounded good.
The committee considered several other proposals including voting down one by Sen. Sherrod Brown (D-OH), which would have provided only 7 years of exclusivity for brand name biologics. Sen. Edward M. Kennedy (D-MA), chairman of the HELP committee, voted by proxy to support the 12-year limit.
The vote was a small victory for major biotech drugmakers, which have been pushing for a period of 12 to 14 years before generic equivalents could be approved. Biotech companies have been pushing for a longer period of data exclusivity saying that it can take 15 years and a $1 billion to develop and market a biotech drug so they need the longer period to make back their investment. Generic drugmakers, not surprising, would like the exclusivity period limited to five or seven years.
This is just as small step since the Senate plan could change when the healthcare bill goes to the floor for a vote. It also must be approved by the House.
So, what will the final number be for exclusivity? Try Follow-On Blackjack [2].