Rebecca Zacks in XConomy provided an excellent overview of a blogosphere controversy that erupted last week over biogenerics legislation, in response to an article run by the Wall Street Journal on Genzyme’s recent difficulties in manufacturing the drug Myozyme at a second plant.
Zacks provided some background to the issue:
Myozyme, approved by the FDA last year for the treatment of an inherited muscle disorder called Pompe disease, could be a big source of revenue for Genzyme—the drug can cost more than $300,000 per year for an adult patient, according to the Journal article. But Genzyme has been unable to scale up production of the drug because the FDA has so far declined to approve a Boston plant meant to be its main source. While the company waits for that approval, it is providing some U.S. patients with free doses from a different plant in Framingham, MA—the one that produced the drug for the clinical trials—on an experimental basis. (The Framingham product is already approved for sale in other countries, but not the U.S.)
What’s stalling approval of the new factory, according the article, is a chemical difference between the Myozyme produced in Framingham and that produced in Boston.
Zack cited Wall Street Journal’s David Armstrong, who followed up on the Journal’s article with the following explanation:
Genzyme is having trouble persuading the FDA to sign off on Myozyme made in big batches. The agency wants to be sure the drug produced in large tanks is the same as the stuff Genzyme made successfully on a smaller scale.
Making biologics is complicated work, and that’s one reason the biotech industry has voiced caution about legislation to allow generic versions of the medicines.
In the case of Myozyme, billions of cells from hamster ovaries growing in large stainless steel tanks produce the enzyme Pompe patients lack. The fact that Genzyme, which has loads of biotech experience, is having such difficulty ramping up production of its own drug heightens worries about the ability of generic manufacturers to accurately copy brand-name biotech drugs.
Even small differences in these drugs could affect patients. Myozyme made in the big tanks contains less of a key carbohydrate that is believed to help certain muscle cells absorb the drug. Less absorption could reduce the drug’s effectiveness.
However, Zacks acknowledged that not all the bloggers give any real credence to the biotech’s industry’s position or to the argument that Myozeme should be a case study for why biogenerics legislation is a bad idea, citing Venture Beat’s David Hamilton, who had his own take on the controversy, arguing that the Wall Street Journal “missed a much more important point about biogenerics: [t]he double standard that the biotech industry holds” on determining the equivalence of different batches of drugs. Hamilton wrote as follows:
The first issue here is that there’s nothing new about biotechs finding that new production batches of a complicated protein differ in certain ways from older batches. . . . Sometimes these differences are serious; more often, they’re not. . . .
The second issue — and those of you who’ve followed these debates can probably see where I’m going — is that the biotech industry wants to have it both ways when it comes to the “complicated work” of making biologics. Where biogenerics are concerned, the industry insists that copycat versions of biotech drugs must undergo those expensive and lengthy clinical trials in the interests of “patient safety.” When it comes to their own drugs, however, biotech companies are perfectly willing to rely on a battery of simpler tests to ensure that a new production batch is equivalent to an old one, and only run clinical trials as a last resort (and when forced to by the FDA).
All of which suggests that it would probably suffice to subject any would-be copycat drug to the same set of tests that biotech manufacturers themselves must meet for a new production facility. If it passes, it’s approved. If not, then it’s time to consider clinical trials. In fact, this is pretty much the “case-by-case” strategy adopted by the House and Senate biogenerics bills — ones that I’m pretty sure the Biotechnology Industry Organization opposed. In any event, it doesn’t seem too much to ask that journalists covering these debates realize that the case against biogenerics is a lot weaker than the industry would like us to think.
All in all, Zacks effectively captured a very interesting blogosphere debate on yet another aspect of the biogenerics controversy. As you know if you follow this blog, I have indicated repeatedly in prior blogposts my view that biogenerics legislation is going to have a negative impact on the biotech industry. I think I would agree with Venture Beat that this is the principal problem with biogenerics legislation, and that the argument that biogenerics legislation will somehow lead to dangerous copies of drugs being on the market is a fairly weak attempt at scaring the public and/or legislators into voting against such legislation. There is already a mechanism in place to regulate drugs on the market–the FDA regulatory powers. The much larger issue is what biogenerics legislation will do to discourage biotech innovations that should be a concern to all of us out there. We all want to be able to afford to buy the drugs we need, but at the same time, we also want access to medications that will make us well when we come down with a horrible illness. We should not lose sight that without a profit incentive to developing those medications, they won’t be available when we need them.
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