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Mylan and Fujifilm Kyowa Kirin Receive the US FDA's Approval for its Hulio (biosimilar- adalimumab)

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Mylan and Fujifilm Kyowa Kirin Receive the US FDA's Approval for its Hulio (biosimilar- adalimumab)

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  • The US FDA has approved Hulio (adalimumab-fkjp)- a biosimilar to AbbVie's Humira (adalimumab) to treat RA- JIA (in patients aged ≥4yrs.)- PsA- AS- adult CD-  UC- and PsO- in both prefilled syringe and auto-injector presentations
  • The approval is on based analytical- pre/ clinical program. The P-III ARABESC study conducted by Fujifilm Kyowa Kirin- demonstrated no differences in terms of safety- efficacy- and immunogenicity compared to its reference product in patients with RA
  • In 2018- the companies collaborated to commercialize Hulio in the EU while expanded the agreement globally in 2019. As per the patent license agreement with AbbVie- Mylan will be able to launch Hulio in the US in Jul’2023

Click here to read full press release/ article | Ref: PRNewswire | Image: Barron's


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