Biogenerics: The Time Has Come
Sorry, Biotechnology Industry Organization, but I just don’t think you’re going to win the battle on follow-on biologics (FOBs) this time. In fact, I’m going to step up the rhetoric a notch and call these “FOBs,” “FOPPs,” or “biosimilars” by a forbidden name: biogenerics (gasp!). It may not be totally accurate to view any biologics as “generic” in the same sense as small molecules, but that’s how the public are going to view them, and that’s how I think the legislation around them is going to shape up.I wrote about biogenerics a little over a year ago, when BIO was in a hurry to push through a friendly bill before the makeup of Congress changed and made their lives more difficult. That might have been a good strategy, but it didn’t happen. I didn’t think then that we’d see a law signed in 2008, but I do think we’ll see something passed in this Congress. BIO is backing a new bill introduced by Reps. Anna Eshoo (D-CA) and Joe Barton (R-TX) that looks a lot like a bill they introduced in the last Congress. It calls for potentially extensive clinical trials for any potential biogeneric and long periods of exclusivity that would make bringing a biogeneric to market almost as onerous as simply doing a whole new BLA. Except now, the follow-on maker wouldn’t have the market exclusivity to make the investment worthwhile.
Of course, I can understand why BIO and its members would like that--it would pretty effectively choke off the biogenerics market in its cradle. But I think that an administration and a public focused on cost savings and greater access to life-saving drugs is going to follow a path closer to that outlined in alternative legislation from Henry Waxman (D-CA) (vehemently opposed by BIO), who would do away with the large-scale clinical trials on biogenerics and make an abbreviated path much closer to that enjoyed by convention generics.
Is that really a safe approach? BIO has insisted that there can’t really be two truly equivalent biologics. And they’re right, of course. But lest we forget, the modern BLA was ushered in back in 1997--with the support of BIO--because it was recognized that the old establishment licensing application was no longer necessary. Under the ELA system, a manufacturer couldn’t just scale up production of a biologic because it was believed that any change--a new tank or hose, a new pH meter--could change the protein being made. Yet we’d already come a long way--and have continued to make progress--in our ability to characterize biologics and determine when one product is close enough to another to be safe. Without recognition that there is such thing as close enough, the modern biotech industry wouldn’t exist.
The Europeans, who have led the way on biogeneric legislation, have come around to viewing follow-on products as near enough to equivalent that they can bear the same name, although the issue of substitutability--whether a pharmacist can substitute a biogeneric for the reference product without consulting a physician--is still controversial and left up to individual countries to determine.
When this debate was heating up in 2007, Rep. Darrell Issa (R-CA) held up a bottle of wine during a hearing and asked whether a $90 bottle of California merlot was really equivalent to a boxed wine. Certainly not. But you can probably count on them having the same biological effect.
--Karl Thiel
