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May 18, 2010
Biosimilars: Not So Dang Easy
This post drew a lot of comments here about how the big companies are going after follow-on biologic drugs. As a late-2008 article put it:
Merck already has one FOB in clinical development: a pegylated erythropoietin for anemia similar to Amgen's Aranesp (darbapoetin alfa) called MK-2578, which is being developed using a sugar-modification technology the pharma obtained via its 2006 purchase of GlycoFi. The company hopes to launch its EPO product in dialysis and pre-dialysis patients with chronic kidney disease in 2012.
Clyburn declined to offer any sales projections for that product or the MBV unit in general, nor would he identify any of the other products or therapeutic areas Merck will attempt to develop. He said MBV will identify product candidates by looking at their value in the marketplace.
Good move to decline those speculations, because Merck just announced recently that they're discontinuing that whole Aranesp-oid project. The FDA made it clear that they'd expect a full human cardiovascular safety workup before approval, which appears to have thrown Merck's numbers off severely, as you might imagine.
There is, and continues to be, no easy way.
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