The falsehoods being spread about biosimilars that don’t match up with reality.
The Biosimilars Report Card
It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has developed are mixed.
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FDA Approves Prolia and Xgeva Biosimilars, Stoboclo and Osenvelt
Fresenius Kabi Launches Otulfi, the 4th Biosimilar of Stelara to Become Available
The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.
Updated: Two More Stelara Biosimilars Launch, Including One that is 90% Off Stelara
There are four biosimilars of Stelara available to treat chronic autoimmune diseases — Wezlana, Selarsdi and now Pychiva and Yesintek.
FDA Approves First Biosimilar of Novolog
Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day supply.
FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.
