Coherus’ Yusimry nabs FDA approval as seventh Humira biosimilar in cramped market
Click Here to Manage Email Alerts
The FDA has approved the seventh biosimilar to adalimumab, adalimumab-aqvh, for all eligible indications of the biologic product, the latest in an increasingly crowded biosimilar logjam set to release in 2023.
Yusimry (adalimumab-aqvh, Coherus BioSciences), a biosimilar to the world’s top-selling Humira (adalimumab, AbbVie), is a TNF inhibitor intended to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
“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,” Denny Lanfear, CEO of Coherus, said in a press release. “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.”
Yusmiry is now the seventh biosimilar to Humira to gain FDA approval in the United States, following the FDA’s approval of Cyltezo (adalimumab-adbm, Boehringer Ingelheim) as the first interchangeable biosimilar for certain inflammatory diseases in October. However, to date, none of these biosimilars have been launched in the U.S. market as Humira is patent-protected until 2023.
The FDA based its approval on a comprehensive data package, which included results from Study CHS-1420-02 — a double-blind, randomized, parallel-group, active-control study that compared efficacy/safety of Yusimry vs. adalimumab in patients (n=545) with moderate-to-severe chronic plaque psoriasis — and Study CHS-1420-03 — a double blind, randomized, single-dose, parallel-group study comparing the relative bioavailability between Yusimry and adalimumab after a single subcutaneous 40 mg dose administered to healthy controls (n=200).
According to the press release, Yusimry carries a boxed warning for increased risk for serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. The prescribing information also includes a warning for a potential increased risk for lymphoma and other malignancies.
“The approval of Yusimry brings a new offering to health care practitioners and their patients with certain inflammatory diseases,” Barbara Finck, MD, chief medical officer of Coherus, said in the release. “We believe high-quality biosimilars provide important alternatives that expand the use of safe and effective medicines to more patients in need. The Yusimry 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.”
Click Here to Manage Email Alerts