FDA Approves First “Biosimilar” Bioengineered Drug

FDA Approves First “Biosimilar” Bioengineered Drug

The Food and Drug Administration has approved Novartis’s Zarxio, an imitation of Amgen’s bioengineered cancer drug Neupogen.  This is the first time that FDA has approved a “biosimilar” – a biological product that has no clinically meaningful differences from a previously approved biologic.  Biosimilars are analogous to generic drugs, although the fact that biologics are derived from living organisms means that biosimilars are not precise copies, as generics are.  The Biologics Price Competition and Innovation Act – part of the Affordable Care Act – gave the FDA authority to approve biosimilars on an abbreviated path that relies on proof of biosimilarity with approved biologics, rather than the full biologic approval process.  Zarxio is the first in what is expected to be a number of biosimilar approvals. [3/6/15]

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