BioPharma Dive February 26, 2024
Jonathan Gardner

Simlandi is the first version of a popular Humira formulation to reach market that can be directly substituted by pharmacists.

Dive Brief:

  • The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
  • The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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