Yusimry, the Seventh Adalimumab Biosimilar, Gains FDA Approval

Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.

The FDA has approved a seventh adalimumab biosimilar, Yusimry, which is developed by Coherus BioSciences.

Yusimry is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. The approval was based on a data package demonstrating the biosimilarity of Yusimry to reference adalimumab (Humira).

Study CHS-1420-02 was a double-blind, randomized, parallel-group, active-control study comparing the safety and efficacy of Yusimry with Humira in 545 randomized subjects with moderate to severe chronic plaque psoriasis. Study CHS-1420-03 was a double-blind, randomized, single-dose, parallel-group study confirming pharmacokinetic similarity.

"The approval of Yusimry brings a new offering to healthcare practitioners and their patients with certain inflammatory diseases,” Barbara Finck, MD, chief medical officer of Coherus, said in a statement. “We believe high-quality biosimilars provide important alternatives that expand the use of safe and effective medicines to more patients in need. The YU Yusimry SIMRY approval was supported by a comprehensive analytical similarity package, as well as comparative pharmacokinetic, efficacy, and immunogenicity studies enrolling patients with moderate to severe chronic plaque psoriasis as well as healthy subjects.”

This is Coherus’ second approved product. The first was a pegfilgrastim biosimilar (Udenyca), which was approved November 2018 and came to market January 2019. There are 3 other pegfilgrastim biosimilars approved and launched in the United States.

So far, none of the approved adalimumab biosimilars have come to market in the United States because of arrangements with AbbVie, the maker of Humira. The earliest Yusimry can launch is July 1, 2023. The first biosimilar expected to launch in the United States will be Amjevita, from Amgen, which was approved September 2016 and has an anticipated launch of January 2023.

The Center for Biosimilars®, a sister site of The American Journal of Managed Care®, noted there is tremendous sales potential for Yusimry given that Humira is the world’s top-selling drug.

Coherus has 2 other biosimilars in the pipeline. An ophthalmology biosimilar (CHS-201), which references Lucentis, is under review with the FDA with an expected decision in August 2022. The company is also developing a bevacizumab biosimilar, CHS-305.