FDA Approves Amgen’s Amjevita

By: Sandy King  |   September 27, 2016

On Friday, September 23, 2016, the U.S. Food and Drug Administration approved Amgen Inc.’s Amjevita, which is the biosimilar equivalent of AbbVie Inc.’s immunosuppressant Humira. The drug is approved for more than a half-dozen conditions listed on the branded drug’s label, including severe psoriasis and Crohn’s disease.

The two companies are already engaged in litigation under the Biologics Price Competition and Innovation Act (BPCIA) over the drug. On August 4, 2016, AbbVie filed a complaint against Amgen under the BPCIA asserting that Amgen’s biosimilar version of Humira infringes ten of AbbVie’s patents and further indicating that 51 other patents may also be infringed. In the complaint, AbbVie expressed frustration with its inability to assert all of the patents in the case. However, AbbVie acknowledged that it will have a second opportunity to assert the remaining patents when Amgen provides the 180-day Notice of Commercial Marketing.

For now, in view of the decision in Amgen v. Sandoz, Amgen will likely proceed with providing 180-day pre-marketing notice to AbbVie. After receiving the post-approval 180-day notice, AbbVie will have the right to assert the remaining patents. We will be providing updates as the litigation evolves.