FDA Approves New Amgen Biosimilar for Adalimumab Save

2016 has been a big year for biosimilars in rheumatology.

On Friday, the FDA announced the approval of Amgen's biosimilar version of Humira. The approval comes roughly 10 weeks after the FDA's Arthritis Advisory Committee unanimously voted, 26-0, in favor of approving ABP 501 based on clinical trials in rheumatoid arthritis (RA) and plaque psoriasis.

The biosimilar was previously referred to as ABP 501 during development and is now given the trade name Amjevita (generically called adalimumab-atto).  Amjevita becomes the fourth biosimilar to be approved by the FDA, and the third biosimilar approved based on currently marketed TNF inhibitors (TNFi).

The new biosimilar will be approved for the same indications as adalimumab: RA, juvenile idiopathic, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, adult Crohn’s disease, and adult ulcerative colitis.

Amgen is expanding its role in the biosimilar market and intends to launch 5 new products between 2017 and 2019, including ABP 215 (a biosimilar of Roche’s Avastin), ABP 980 (Herceptin for breast cancer), ABP 798 (Rituxan bioisimilar), ABP 494 (Eli Lillys Erbitux), and ABP 710 (Remicade).

This approval marks an interesting change in the life cycle of Humira, the second-biggest selling drug in 2015.  Humira's current list price is $53,260 a year, and had $8.4 billion in sales last year (or about 60% of AbbVie’s revenue).

The actual appearance of this and other biosimilars is currently unknown and may be delayed, as the makers of the biosimilars and originators are currently in the courts to settle claims against one another.