October 31, 2018: FDA Approves Sandoz’s Biosimilar Adalimumab, Hyrimoz
The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).
The drug has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis…
Despite today’s approval, US patients will have to continue to wait for access to Hyrimoz, as the biosimilar will not enter the US market until 2023. Earlier this month, Sandoz announced a global settlement of patent disputes with AbbVie over the drug. While the settlement allowed Sandoz to launch Hyrimoz in the European Union on October 16, 2018, it forestalled US market entry until September 30, 2023.
My take: Why will this biosimilar be allowed in Europe but not U.$?
Related blog posts:
- NY Times: Humira’s Best-Selling Drug Formula: Start at a high price. Go higher
- Orphan Drugs –Very Profitable (Humira is labelled an orphan drug!)