On Friday, 9/23, the FDA approved the first biosimilar version of AbbVie’s Humira.
Developed by Amgen, Amjevita™ (adalimumab-atto) has been approved to treat the following inflammatory diseases:
- Moderate-to-severe rheumatoid arthritis
- Moderate-to-severe polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Moderate-to-severe chronic plaque psoriasis
- Adult moderate-to-severe Crohn’s disease
- Moderate-to-severe ulcerative colitis
The approval of Amjevita follows in the wake of two Phase 3 studies that each met their primary endpoint (showing clinical equivalence to adalimumab) in patients with severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The most common adverse reactions with Amjevita, according to the FDA, are infections and injection site reactions.
“Approval of Amjevita is an exciting accomplishment. . . Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” said Sean E. Harper, M.D., Executive Vice President of Research and Development at Amgen.
AP reports that, in 2015, Humira posted sales of approximately 15 billion and is the second-best selling drug in the world. Humira was approved in December 2002 and accounted for 60 percent of AbbVie’s total revenue in 2015.
It is important to note that Amjevita has been approved as a biosimilar, not as an interchangeable product.
“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.
According to FirstWord Pharma:
Novartis’ Zarxio (filgrastim-sndz), a biosimilar of Amgen’s Neupogen (filgrastim) approved in March 2015, was the first biosimilar cleared in the US. Earlier this year, the agency approved Celltrion’s Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson’s and Merck & Co.’s Remicade (infliximab), followed by Novartis’ Erelzi (etanercept-szzs) as a biosimilar version of Amgen’s Enbrel (etanercept) last month.
Amgen’s Amjevita is currently undergoing review by the European Medicines Agency and is one of nine programs included in Amgen’s biosimilar pipeline.