biosimilar

Small biotech campaigns for biogenerics law

John Carroll — Thu, 14 Aug 2008 11:12:09 -0400

The small biotech Insmed has been lobbying for new legislation that would clear a regulatory pathway for biosimilars. The Richmond, VA-based company wants to develop a portfolio of follow-ons and CEO Geoffrey Allan has been patiently educating lawmakers on the intricacies of biologics and how biosimilars could be made safely and inexpensively. Insmed has already mounted a small trial for its version of Amgen's Neupogen, which is on just about everyone's list of biologics most likely to face competition first.

Of course, Insmed's argument is diametrically opposed to the Biotechnology Industry Organization's, which has been campaigning for years to make sure any biosimilar law would require extensive trials after a prolonged period of exclusivity.

- read the report in the Washington Post

Genzyme gets biosimilar rejection, builds R&D plant

Tue, 22 Apr 2008 06:59:58 -0400

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This rejection underscores the difficulty biosimilars face in the United States. "The FDA decision...suggests that regulators may be reluctant to approve any generic versions of biologic drugs...without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds," observes the Boston Globe. Currently, the U.S. has no pathway to quickly approve biosimilar drugs.

As Genzyme points out, Myozyme production has already been scaled up in 40 other countries. "Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale...Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe," the company said in a statement. The company expects the FDA to act on the application by the end of the year.

- see this release from Genzyme
- read the Boston Globe article

ALSO: Genzyme is opening a major new R&D center in Beijing. The facility will house 350 employees and will cost an estimated $90 million. Researchers in the Beijing plant will develop drugs in four focused areas: orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. According the the release, the R&D facility "is part of Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China." Report

Waiting game continues for biogenerics

Mon, 10 Sep 2007 06:59:59 -0400

The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on biosimilars was unlikely to reach the House floor this week. He chalked the delay up to scheduling issues. Of course, with the Democrats in charge of the House and Senate, one wonders why a piece of legislation like this can't go ahead swiftly. It's more than apparent that lawmakers are willing to create a regulatory pathway for generic versions of biotech drugs. And they'll more than likely follow the FDA's position that each of these biogeneric--or biosimilar--applications should be reviewed on a case-by-case basis. Where regulators see complexity in a biologic, they will raise the bar on data. Where a therapy can be copied without raising serious safety issues, which is now done routinely, it will be approved without a terribly demanding set of trials.

All of that is clear enough. So why the delay? I suspect lawmakers are just finding it tough to get their act together. That's one good reason for the growing level of public frustration at lawmakers of every stripe. PDUFA legislation will go ahead because it has to. The FDA needs the money to operate. Meanwhile, the demand for less expensive biologics will only grow. Does anyone in Washington know how this game is played? - John Carroll

Biogeneric Epo approved by EU

Fri, 31 Aug 2007 06:59:57 -0400

Novartis' generic drug arm Sandoz has scored a key victory in the drive for biosimilars. The EU has approved its biogeneric epoetin alfa for patients with renal anemia and those receiving chemotherapy. The decision is likely to add pressure on lawmakers and the FDA to come up with a well defined regulatory pathway for biosimilars in the U.S. Biotech lobbyists have argued strenuously that biologics are too complex to warrant any kind of generic drug process similar to that allowed for traditional drugs. But as European regulators approve more and more of these applications, they will continue to demonstrate that not all biologics are created with equal complexity.

- here's the AFX report for more information