Yesterday, the FDA approved its third biosimilar product, Sandoz’s biosimilar version of Amgen’s Enbrel® (etanercept).  The drug, named Erelzi (etanercept-szzs), was approved for the same indications listed on Enbrel®’s label, including rheumatoid arthritis, psoriasis, and other immune system disorders.  The other two biosimilars the FDA has approved are Sandoz’s Zarxio® (filgrastim-sndz) biosimilar of Amgen’s Neupogen® and Pfizer’s Inflectra® (infliximab-dyyb) biosimilar of Johnson & Johnson’s Remicade®.

However, it may be some time before Erelzi enters the US market.  On February 26, 2016, Immunex Corp., Amgen Manufacturing and Hoffman-La Roche filed suit against Sandoz under the “patent dance” provisions of the Biologics Price Competitions and Innovation Act (“the BPCIA”), asserting five patents that cover etanercept.  While discovery is currently underway, on August 11, the court entered a consent preliminary injunction order, which prohibits Sandoz from making, using, importing, selling or offering to sell its biosimilar product.  Further details regarding the injunction are unavailable at this time since the stipulation that led to the injunction is sealed.  Trial regarding the validity of the five patents-in-suit is set for April 17, 2018.

Last year, Enbrel® accounted for approximately $5.36 billion of Amgen’s total product sales.  Interestingly, Amgen, the biologic manufacturer, in this case, has taken on the role of a biosimilar applicant, announcing plans to launch several biosimilars, including a biosimilar version of AbbVie’s drug Humira®.

We will continue to monitor activity in this area and provide updates.