"Generic" biologics: Another biotech battle begins

A second legislative fight for the biotech industry is shaping up in Washington over whether to give the Food and Drug Administration authority to approve “generic” versions of biotechnology drugs whose patents have expired.

Measures that would grant FDA that authority, introduced separately in the House and Senate, are billed as a natural cost-saving measure by supporters. They note the high cost of many biotech drugs and the fact that several best-sellers are expected to go off-patent over the next few years. To biotech’s biggest companies and their lobbyists, however, the effort could jeopardize public safety and the incentives that lead companies to spend vast sums in search of new drugs in the first place — at least unless the copycat products are required to go through the same arduous and expensive clinical trials as their brand-name counterparts.

Here, the industry relies on an argument that is one part science and one part misdirection. Biotech drugs generally consist of large, complex proteins that are much more difficult to understand than the relatively straightforward active chemical ingredients in traditional pills. The industry argues that it’s impossible to analyze copycat biotech drugs thoroughly enough to know whether or not they’re identical — or at least close enough — to a name-brand version. Which, of course, leads to the demand that copycat biologics run the same human-trial gauntlet as name-brand drugs, a requirement that might run up development costs so high that a “generic” biotech drug wouldn’t necessarily be any cheaper than its rival.

The problem here is that some biotech-drug proteins aren’t so complex as to defy analysis. The FDA, for instance, already approved a copycat version of human growth hormone called Omnitrope a year ago, after a variety of laboratory and limited human tests allowed FDA scientists to determine that it was “highly similar” to its name-brand cousin. That sort of testing isn’t possible for all biologic proteins, but as analytical laboratory technology gets better, so will the FDA’s ability to correctly assess the similarity of even complex protein drugs. Last month, in fact, FDA Deputy Commissioner Janet Woodcock testified before Congress that the agency already has the skills to make those assessments in some cases. Since the bills in question simply give the FDA the authority to authorize copycat versions of biotech drugs when the evidence warrants it, it’s hard to see what all the shouting is about.

Except, of course, that this fight — like most such Beltway brawls — is at heart about money. Unlike Big Pharma, which has to brace itself for generic competition every time a billion-dollar drug approaches the end of its patent lifetime, biotech companies face little threat of pricing pressure even when patent protection lapses on their cash cows (such as Amgen‘s Epogen, a version of the erythropoietin molecule pictured above). Given that annual costs for many best-selling biotech drugs run into the tens of thousands of dollars — even hundreds of thousands in some cases — the green at stake is truly astonishing.

As for the innovation argument, it helps to remember that patents are limited, artificial monopolies created for public-policy reasons that are written into the Constitution itself. If innovation in the biotech industry really depends upon perpetual monopolies over incredibly expensive drugs — well, let’s just say that this is not an argument you’re likely to hear explicitly from a biotech representative any time soon.