By Donald Zuhn —

Last Thursday, Senator Charles Schumer (D-NY) (at right) introduced the Promoting Innovation and Access to Life-Saving Medicine Act (S. 726), the first follow-on biologics bill to be introduced in the Senate and third follow-on biologics bill to be introduced in the 111th Congress.  The new bill is the Senate companion to the bill (H.R. 1427) introduced in the House on March 11 by Representative Henry Waxman (D-CA).  On March 18, Representative Anna Eshoo (D-CA) provided an alternative to Rep. Waxman's bill, when she introduced the Pathway for Biosimilars Act (H.R. 1548).  As with Rep. Waxman's bill, Sen. Schumer's bill would provide up to 5.5 years of exclusivity, while Rep. Eshoo's bill would provide up to 14.5 years of exclusivity.

Under a subheading stating that the "Measure Would End Brand-Name Drugs' Monopoly By Allowing Cheaper, Generic Versions To Compete," a press release issued on Sen. Schumer's website asserted that S. 726 "would save federal programs like Medicare and Medicaid at least $10 billion dollars by bringing needed competition to the marketplace."  The press release noted that the five-year window of exclusivity that brand name biologics would generally receive would begin at the time the brand name biologic was first approved, rather than at enactment of the bill, and therefore, that generic drug manufacturers could "seek approval for more affordable versions [of such biologics] almost right away."

Senator Schumer argued that it was "past time we created a way for generic versions of these expensive drugs to come to market," adding that "[t]he savings reaped from this will be a down payment on health care reform."  Pointing to the high cost of biologic drugs in general, and the $100,000 annual cost for administering the cancer drug Avastin in particular, Senator Susan Collins (R-ME), one of the bill's seven co-sponsors, argued that "[p]eople who need [biologic drugs] should not be denied access solely on the basis of cost," and contended that "[u]sing competition to bring generic versions of these medicines to the market will help offer patients, employers, and federal and state health programs cost savings."  The press release also notes that Avonex, which is used for the treatment of multiple sclerosis, is "[o]ne of the most popular biotech drugs" despite costing almost $20,000 a year.  Interestingly, the release acknowledges that Avonex has been off patent since 2003.  Senator Mel Martinez (R-FL), who also co-sponsored the bill, said that "[b]y striking the right balance between competition and rewarding innovation," the new bill would "encourage the development of new treatments while driving down the cost to consumers."

In response to the introduction of S. 726, the Biotechnology Industry Organization (BIO) issued its own press release, in which BIO President and CEO Jim Greenwood stated that the Senate bill "follows its companion bill in the House . . . through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs."  According to Mr. Greenwood, S. 726 would "create[] an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases," by "unfairly tilt[ing] the playing field toward biosimilars manufacturers."  In particular, Mr. Greenwood contended that: