FDA Approves Mylan’s Biosimilar of HUMIRA (Adalimumab)



On July 6, 2020, the U.S. FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA. HULIO is indicated for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HUMIRA, in contrast, is additionally approved for the treatment of certain patients with pediatric Crohn’s disease, hidradenitis suppurativa, and uveitis.

HULIO is the sixth biosimilar of HUMIRA to obtain FDA-approval, following Amgen’s AMJEVITA (adalimumab-atto) in September 2016, Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm) in August 2017, Sandoz’s HYRIMOZ (adalimumab-adaz) in October 2018, Samsung Bioepis’s HADLIMA (adalimumab-bwwd) in July 2019, and Pfizer’s ABRILADA (adalimumab-afzb) in November 2019. None of these biosimilars are yet on the U.S. market, however, as each biosimilar applicant has entered into a license agreement with AbbVie that permits the applicant to begin U.S. marketing only after a specified date in 2023. As we previously reported, AbbVie has granted the following U.S. license dates:

  1. Amgen: January 31, 2023
  2. Samsung Bioepis: June 30, 2023
  3. Boehringer Ingelheim: July 1, 2023
  4. Mylan: July 31, 2023
  5. Fresenius Kabi: September 30, 2023
  6. Sandoz: September 30, 2023
  7. Momenta: November 20, 2023
  8. Pfizer: November 20, 2023
  9. Coherus: December 15, 2023

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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