“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 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.
[…] The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee 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.</pRead more at https://patentbaristas.com/archives/2009/07/14/senate-committee-12-years-of-data-exclusivity-is-c… […]
[…] for Congress Matters. Click here for the morning session and here for the afternoon session . Senate Committee: 12 Years of Data Exclusivity is Cool – patentbaristas.com 07/15/2009 “To amend the public health service act to establish a […]
[…] in favor of allowing 12 years of data exclusivity for biotech drugs. The change on data exclusivity follows the similar amendments by the Senate Health, Education, Labor and Pensions […]
[…] This kind of copy-cat competition, which allows a competitor to “use†(i.e., steal) the innovator’s research, does not exist in virtually any other industry outside of drugs. In fact, such copy-cat competition does not even exist today for biologics at all, which is why in order to authorize such a short-cut, non-innovative path to market Congress must enact legislation to authorize the FDA to use an abbreviated approval process for biosimilars. Despite the misrepresentations made by many, the innovator biotechnology industry has never argued that short-cut competition should exist, but has advocated for a fair and reasonable length of exclusive protection before such short-cut competition is allowed to exist. So the question is not whether this kind of competition should be possible, but rather how long an innovators’ data should be protected before they can be used by non-innovators who will piggyback on the large R&D investment made by the innovator to gain approval of a competitive product. This period of time is referred to as data exclusivity. The innovator biotech community has urged Congress for 12 to 14 years of data exclusivity, the Federal Trade Commission has concluded in a lengthy report that zero years of data exclusivity is appropriate, President Obama has suggested that 7 years of data exclusivity is appropriate and Congress has so far agreed with the biotech industry and supported 12 years of data exlusivity. […]