On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Chron’s disease, ulcerative colitis, and plaque psoriasis. (AMJEVITA Label – FDA.) Humira® was approved for treatment of these conditions back in 2002. Humira® is also approved for treatment of juvenile Chron’s disease, hidradenitis suppurativa, and uveitis. (HUMIRA Label – FDA.) In 2015, Humira® accounted for $8.4 billion in revenue in the United States alone, with worldwide sales of over $14 billion. (AbbVie Full-Year 2015 Financial Results.)

The three other FDA approved biosimilars are Sandoz’s Zarxio® (filgrastim-sndz), Pfizer’s Inflectra® (infliximab-dyyb), and Sandoz’s Erelzi® (etanercept-szzs), and are summarized in the table below.

Amjevita® is the subject of ongoing litigation in the U.S. District Court for the District of Delaware (Civ. No. 16-666-SLR). In this litigation, AbbVie is seeking an injunction to prevent Amgen from selling Amjevita®. AbbVie identified 61 patents it asserts that Amgen infringed with Amjevita®, but for procedural reasons due to the patent dance of the BPCIA, the initial phase of litigation has been limited to ten patents. (See Counterclaims and Answer of Defendants-Counterclaim Plaintiffs Amgen Inc. and Amgen Manufacturing Ltd. at 7-9, citing Amgen Inc. v. Apotex Inc., No. 2016-1308, slip op. at 6, 18 (Fed. Cir. July 5, 2016).) Amgen is the biosimilar manufacturer here, though it has litigated and is litigating many other cases as the reference product sponsor.

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