By Donald Zuhn --
IPO Continues to Support 14-Year Exclusivity Period
The Intellectual Property Owners Association (IPO), reporting on last week's announcement that the White House believes a 7-year data exclusivity period "strikes the appropriate balance between innovation and competition," reminded its members today that the IPO Board adopted a resolution in September 2008 supporting legislation that "promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population" (see "Follow-on Biologics in the News - No. 1" for the complete text of the IPO resolution).
More on OMB Letter to Rep. Waxman
According to a Bloomberg report, the letter sent by Office of Management and Budget (OMB) officials to Rep. Henry Waxman (D-CA) last week in which the White House backed a 7-year data exclusivity period (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics"), also called the 7-year period a "generous compromise." The report speculated that this choice of language was likely influenced by President Obama's request earlier this year that Congress pass follow-on biologics legislation providing an exclusivity period "generally consistent" with that provided for small molecule therapeutics under the Hatch-Waxman Act. Bloomberg also reported that the letter from the OMB stated that the White House was conducting "a serious review of FDA's existing authorities" to ensure that the agency can quickly begin approving follow-on biologics once legislation is passed.
The report also included a statement from Amgen Inc. spokesperson David Polk, who contended that "[w]ithout a fair and sustainable cycle of investment and returns in innovative R&D, biotech discovery will be stifled," adding that the company looked forward to working with Congress on follow-on biologics legislation that "strikes a necessary balance."
Japan Approves First Follow-on Biologic
On the same day that the White House delivered its follow-on biologics letter to Rep. Waxman, a Reuters report noted that Japan had approved its first follow-on biologic, Somatropin, a generic version of human growth hormone from Novartis AG's generic unit Sandoz. Somatropoin, a biosimilar of Pfizer Inc.'s Genotropin, has been approved in Japan for the same range of diseases as Genotropin, including the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency. In Europe and the U.S., the drug has already been approved as Omnitrope (see "Congressional Fact-finding on Follow-on Biologics" and "Three New Biosimilars Pass EMEA Test").
San Jose Mercury News Backs Eshoo Bill
In an editorial in last Wednesday's edition of the San Jose Mercury News, the Silcon Valley newspaper voiced support for Rep. Anna Eshoo's (D-CA) follow-on biologics bill (H.R. 1548), which provides up to 14.5 years of data exclusivity and currently has 108 co-sponsors. Rep. Henry Waxman's (D-CA) competing bill (H.R. 1427) provides up to 5.5 years of data exclusivity and has 12 co-sponsors. In discussing its endorsement of the Eshoo bill, the editorial states that:
Legislation in Congress could determine whether [biotech] research goes forward or stalls in Silicon Valley and other biotech centers.
The issue is essentially patent protection: the length of time companies have to at least try to recover the $1 billion or more in investment it can take to bring one of these drugs to market. For each biologic breakthrough, other companies are waiting to introduce biosimilars -- basically, generics -- at lower prices.
The dilemma goes to the heart of President Barack Obama's goal for comprehensive health care reform: Can the nation continue to spark health care innovation at the same time it guarantees access to affordable medical care, including medication? Can it save the billions of dollars a year we know is wasted in the current system without undercutting incentives for excellence? Health care reform will fail if it stalls research and medical progress. When Congress takes up regulation of biosimilars later this year, it needs to shore up the incentive for promising biologics research.
The editorial calls the Eshoo bill "smart, science-based legislation that puts a premium on patient safety and encouraging further innovation." Noting that "[h]olding down cost is a worthwhile goal," the newspaper argues that "these medicines won't exist in the first place if research dries up, or if safety issues crop up with the biosimilars." As for lowering costs, the editorial contends that
"as their use increases and more new drugs come onto the market to attack debilitating diseases, savings will kick in."
Teva Unveils "Man on the Street" Videos
As part of Teva's "Year of Affordable Healthcare" campaign, which the company describes on the campaign's website as "a nationwide call for increased access to affordable healthcare for American citizens [that] coincides with the 25th anniversary of the landmark Hatch-Waxman Act," Teva has released the first in a series of "man on the street" videos in which Washington, DC residents were asked to comment on U.S. healthcare, and particularly on the need for follow-on biologics.
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