TheStreet.com's Feurstein Fast and Loose With Remicade Pricing Truth
There is a reason we ask for the whole truth. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
BioBummer
The FDA has decided to postpone the March 17th meeting of the Arthritis Advisory Committee. The adcomm was supposed to discuss Celltrion’s infliximab biosimilar application. The Pink Sheet proclaimed this a “Biosimilar Bummer.” A bummer for Celltrion to be sure, but the lesson to be learned is that the filgrastim adcomm, viewed by many as a FDA love-fest should not be viewed as a broader predictive regulatory response to every biosimilar application. Many saw it as such because they wanted it to be true. Bummer? Not if you understand that the decision tree for biosimilars is quite different from the Hatch-Waxman path...
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
Rheums with a View
Today the FDA’s Arthritis Advisory Committee heard presentations on whether or not the agency should approve a BLA from Celltrion Inc. for CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson. Despite open public comment from patients and physicans concerned about extrapolation issues, the vote was 21-3 in the affirmative. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
