FDA approves Humira biosimilar, but it won't hit the market for 4 years

The FDA has approved Hadlima, a biosimilar to AbbVie's blockbuster rheumatoid arthritis treatment Humira. However, it won't be available in the U.S. until June 2023.

The delayed launch date is a result of a negotiated intellectual property settlement with AbbVie, according to EndPoints News. 

Under the settlement, Hadlima will be the second Humira copycat to enter the U.S. market, after Amgen, but before Mylan and Sandoz release their own biosimilars 

Hadlima is manufactured by Samsung Bioepis and is approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. It contains a black box warning about risks of infection and lymphoma.

More articles on pharmacy:
Oklahoma opioid trial wraps: 10 takeaways
Drugmaker tried to shred records before FDA inspection, agency claims
Publix Pharmacy to deliver prescriptions to patients before hospital discharge

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months