Last week, Coherus BioSciences, Inc. (“Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™, an adalimumab biosimilar. YUSIMRY™ is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. This is the seventh biosimilar to be approved for AbbVie’s blockbuster immunosuppressant Humira® (adalimumab).
“We are excited that Coherus has received FDA approval for YUSIMRY, our second approved product, and we are grateful to the patients and investigators who participated in our clinical trials and for the dedication of employees across all functions at Coherus,” said Denny Lanfear, CEO of Coherus. “Growth and diversification of our biosimilar portfolio is a high priority for Coherus — first and foremost as it enables greater patient access to important medicines — and because revenue from these products will fund the continued investment in our innovative pipeline programs that will drive our future growth.” As we previously discussed, AbbVie’s Humira® is the world’s most profitable drug with sales reaching close to $20 billion in 2020, over $16 billion of which were U.S. sales revenue. In 2021, AbbVie reported with an increase in sales of Humira® in the U.S., but as predicted, a decrease of sales internationally due to biosimilar competition in other parts of the world.
Humira® was first approved in December 2002 and has enjoyed exclusivity in the U.S. market for the last 19 years, even though multiple adalimumab biosimilars have been approved by the FDA starting in 2016. As we previously discussed, this exclusivity was due to AbbVie’s patent thicket hindering biosimilar competition. After a series of patent lawsuits and settlements, including with Coherus, biosimilar versions are slated to launch in the U.S. starting in 2023. Coherus’ press release indicates that it will launch YUSIMRY™ in the U.S. on or after July 1, 2023, per the terms of its agreement with AbbVie.
