• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

FDA Approves Hulio, the Sixth Biosimilar to Humira


Along with the other Humira biosimilars, Hulio will not be on the market till 2023.

The FDA has approved another biosimilar to Humira (adalimumab) and with that approval, 28 biosimilars all together. But only 17 are on the market and none of the currently aprpoved Humira biosimilars will be available till 2023.

The agency quietly (it didn’t put out a press release) approved Mylan’s Humira biosimilar Hulio (adalimumab-fkjp) on Monday. Hulio is the sixth biosimilar to Humira that has been approved by the federal agency. The others are Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd) and Hyrimoz (adalimumab-adaz)

Humira’s manufacturer, AbbVie, has contracted with all six Humira biosimilar developers for launch dates in 2023, according to our colleagues at the Center for Biosimilars. Three other companies with unapproved Humira biosimilars may also be in the mix


By competing on price with expensive biologics, biosimilars are supposed to be a market-oriented way of lowering healthcare costs. But patent and other issues have kept FDA-approved biosimilars off the market, somewhat stunting the market dynamics that proponents were hoping for. That may change in 2023 when Humira, which has been the top selling drug by sales revenue for many years, is expected to face an onslaught of FDA-approved competitors.=

Hulio is the second biosimilar approved by the FDA this summer. The agency approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim)in June.

Related Videos
"Payer-Provider Collaboration Driving Biosimilar Utilization"
Biosimilar K-Cast - "Overcoming Challenges Associated with Biosimilars"
Biologics video - "The Benefit Channel" Pharmacy Benefits and Medical Benefits
Related Content
© 2024 MJH Life Sciences

All rights reserved.