Nearly a year ago, the FDA approved their first biosimilar, Enoxaparin. However, since the approval there are still questions as to whether or not this biosimilar is actually a biosimilar.
The Generic and Biosimilars Initiative points out that that it is not a therapeutic protien, Lovenox was not approved as a biologic, and the BCPI Act was not in place when the approval process was initiated. If the FDA would release guidelines as to what they view as actual biosimilars and what comprised of them, this would not be a debate.
Join the debate at the
Business of Biosimilars & Biobetters event as Bruce Leicher (Momenta Pharmaceuticals), Brian Harvey (Sanofi-Aventis) and Steven Goldberg (Express Scripts) discuss the usefulness of the Abbreviated Pathway on September 20 at 2:30.
What would the FDA need to offer to make the pathway worthwhile?
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