The last couple of days have seen a flurry of blogging about biogenerics (or biosimilars or follow-on biologics, depending on your take on the issue), prompted in part by a Wall Street Journal article about Genzyme’s troubles scaling up production for a recently approved enzyme drug.
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. “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,” writes the Journal‘s David Armstrong in a blog post following up on the Myozyme article, which he co-authored. “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,” he adds.
VentureBeat’s David Hamilton picked up the thread today—and took issue with Armstrong’s take on the Myozyme example. He writes 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.”
Meanwhile, Melanie Senior at the IN VIVO Blog questions the market for biogenerics by looking at the example of Omnitrope, which she characterizes as “the first biosimilar drug approved in Europe and the only one available on both sides of the Atlantic.” (For a nice illustration of just how contentious this field is, check out the FDA’s Q&A on Omnitrope, which refutes the commonly held idea that the drug is a generic biologic.) Senior writes that despite the fact that Omnitrope sells at a discount of 20 to 30 percent over the innovator drug, “education and perception are blocking widespread uptake.” Based on her interview with Ajaz Hussain, vice president and Global Head of Biopharmaceutical Development at Sandoz, Omnitrope’s manufacturer, Senior writes: “Sandoz reckons it needs more competition to help it drive wider acceptance and trust of biosimilars among prescribers, but not too much so as to render the economics of the game impossible.”
All interesting stuff, and sure to evolve over the weekend. We’ll keep an eye on it.
