BREAKING NEWS: FDA Approves Amgen’s Humira Biosimilar

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today.  If approved, it will be the first biosimilar adalimumab product approved by FDA, and the fourth product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars (first was Sandoz’s Zarxio (filgrastim) biosimilar to Amgen’s Neupogen, second was Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab), and third was Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept)).

Amgen’s adalimumab product is currently the subject of pending litigation in AbbVie v. Amgen.

UPDATE (9/23/2016): FDA has approved Amgen’s adalimumab biosimilar, Amjevita.