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January 15, 2011 (Vol. 31, No. 2)

Biosimilars Carve Out Unique Identity

Building a Case for Side-by-Side Clinical Trials for Biosimilars and Originator Drugs

  • Last November’s FDA public hearings on the approval pathway for biosimilars further highlighted the growing divide and upcoming challenges associated with deeming a biosimilar “highly similar” to the originator. This language comes from the Patient Protection and Affordable Care Act signed by President Obama in March 2010. Although ...

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