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

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

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

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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