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Celltrion's Humira biosimilar receives FDA approval for new dosesBy Shim Woo-hyun
Published : Oct. 4, 2023 - 16:49
Celltrion announced Wednesday that the company received approval from the US Food and Drug Administration for two more dose versions of its Humira biosimilar Yuflyma, for 20 and 80 milligrams.
Yuflyma is a copycat version of AbbVie’s blockbuster drug Humira, used to treat many inflammatory conditions in adults such as rheumatoid arthritis and psoriatic arthritis.
With the FDA’s latest approval, Celltrion is now able to sell three different dose versions of Yuflyma in the US. The 40 mg version was approved in May this year.
The addition to the higher and lower dose versions of Yuflyma will allow doctors and patients to choose the right dosage. “Depending on their indications, doctors will be able to prescribe 80 mg injections for adult patients and 20 mg for pediatric patients,” Celltrion said.
Celltrion also expected that the FDA’s recent approval will help Yuflyma gain a competitive edge over its competitors in the US market, as there are currently not many pharmaceutical firms that can offer high-concentration adalimumab biosimilars in different dose versions.
Sales of high-concentration adalimumab biosimilars are expected to remain high as well, as they can make injections easier and faster by delivering the same amount of medication in a smaller amount of liquid, Celltrion noted.
According to IQVIA and Symphony Health’s data, sales of high-concentration adalimumab accounted for around 85 percent of the total adalimumab sales in the US market, Celltrion cited.
Celltrion added that the company plans to complete its clinical study that will support the interchangeability of Yuflyma with Humira within this year.
Celltrion is also developing an oral form of Yuflyma with Rani Therapeutics, a clinical-stage biotherapeutics company that focus on the oral delivery of biologics and drugs.
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