Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi® and Amjevita®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel®.  The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA.  Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions.  Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

Notably, Erelzi is only the third biosimilar product to be approved under the Biologics Price Competition and Innovation Act (“BPCIA”).

On September 23, 2016, FDA approved Amgen’s application for a biosimilar of AbbVie’s Humira® (adalimumab).  Amgen’s product is called Amjevita, and it will be the first biosimilar of adalimumab in the United States. Amjevita is approved for multiple inflammatory diseases, including moderate to severe rheumatoid arthritis, plaque psoriasis, and Crohn’s disease.  It is also indicated for severely active polyarticular juvenile idiopathic arthritis in children four years of age and older.

Amjevita is approved as a biosimilar, not an interchangeable, product. It is identified as adalimumab-atto.

Despite the FDA’s approval of these two biosimilars, they will not be available immediately. The Federal Circuit recently confirmed that a biosimilar applicant must provide notice of commercial marketing to the reference product sponsor after the FDA approves the biosimilar product and cannot launch its product until 180 days following that notice.  This means that the soonest Sandoz and Amgen will be able to market their biosimilars will be 180 days from the date of FDA approval of the applications.  Additionally, both products are the subject of litigation and have been the subject of inter partes review proceedings, which may further delay market entry.

By: Margaux L. Nair, Trevor M. Gates, Peter Giunta


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