FDA Approves Hulio, the Sixth Biosimilar to Humira

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.