Biogenerics in '08?
Burnt out on the 2008 race for the White House before the contestants are even selected? I hear ya. But with the two nominees soon to be determined--perhaps as early as the March 4 primaries in Ohio and Texas--we get to move to the next phase of the game: What will a Clinton, McCain, or Obama Presidency mean for our industry?
Needless to say, the wonks and lobbyists responsible for helping to shape legislation are way ahead of the game. And one issue that has already raised its head again is, excuse the expression, biogenerics.
Okay, some people don't like that term, arguing that there can't be generic biologics in the same way there can't be generic wine. There's just too much going on to make one product a true copycat of another. Some prefer "follow-on protein product" (except they're not all proteins--just ask Momenta about its stalled heparin product), and...well, you can see where it gets a little messy. So messy, in fact, that despite considerable momentum in the last legislative session, no bill to expedite approval of "subsequent entry biologics" (the Canadians' preferred term) reached a full vote.
President Bush, however, recently resurrected the issue in his 2009 budget request for FDA, saying he "will seek new statutory authority to allow FDA to approve abbreviated applications for certain biologic products...." Already, one new bill from Rep. Anna Eshoo (D-Calif.) (thank you for spotting this, FDA Law Blog) is ready to enter the fray, offering a new wrinkle on various bills introduced last year by Reps. Henry Waxman (D-Calif.), Jay Inslee (D-Wash.), and a Senate compromise from Ted Kennedy (D-Mass.), Mike Enzi (R-Wy.), Hilary Clinton (D-NY), and Orrin Hatch (R-Utah). John Dingell (D-Mich.), chair of the House Energy and Commerce Committee, has also said he is seeking to craft a proposal.
The main points of contention with an abbreviated approval pathway for biologics is a) what kind of clinical evidence will be required to show similarity and/or interchangeability with the reference drug, and who will have discretion on when those studies are required; and b) what kind of exclusivity period the innovator company will get.
The Biotechnology Industry Organization (BIO) would in its heart of hearts love it if biogenerics never saw the light of day. But it has taken a practical tack to dealing with the issue. The trade group was vehemently opposed to Waxman's bill last year, and didn't much like the Kennedy/Enzi/Clinton/Hatch compromise measure, but offered tepid support for Inslee's proposal. We'll have to see what they think of Eshoo's bill, which should please them in that it offers a way to extend exclusivity up to 14.5 years. However, BIO would like to force clinical trials of products, and Eshoo would leave the FDA with broad discretion on waiving trials.
Of course, President Bush's declared wishes for a biogeneric pathway may not hold much sway in his final year. And while all three viable presidential candidates have spoken in support of creating some sort of expedited approval process, they couldn't spearhead much activity until 2009. So is it another year of waiting?
Probably. But BIO has reportedly decided it would actually prefer the devil it knows to what could be a Congress further stacked in favor of Democrats seen as more friendly to the generic drug industry. According to Pharmalot, the trade group doesn't want to "start all over again" with a new crop of lawmakers. And all of a sudden, the Generic Pharmaceutical Association isn't in such a hurry.