Competition Strengthens for Humira Market With Approval of Second Biosimilar

The approval for adalimumab-adbm comes a year after the first adalimumab biosimilar, by Amgen, was approved in September of 2016.
Surabhi Dangi-Garimella, PhD
August 26, 2017
The FDA has approved the tumor necrosis factor (TNF) inhibitor adalimumab-adbm (Cyltezo) injection for subcutaneous use in patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis.

Developed by Boehringer Ingelheim (BI), this is the second adalimumab (Humira, Abbvie) biosimilar to be approved in the United States, nearly a year after adalimumab-atto (Amjevita, Amgen) was approved by the FDA in September 2016.

The most serious adverse events with adalimumab-adbm include infections and malignancies. The FDA has included a serious boxed warning for serious and sometimes fatal infections, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections from other opportunistic pathogens. TNF blockers also increase the risk of lymphomas and other malignancies, particularly in young children and adolescents, according to the product label.

Abbvie, which has a multi-billion dollar market for the reference product, had filed a complaint against BI in a Delaware federal court earlier this month claiming that BI will infringe on 74 of its patents for adalimumab in its development of this product.  

x-button

Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2019 Intellisphere, LLC. All Rights Reserved.