Humira biosim wins FDA approval

July 24, 2019

The clock is ticking on how much longer the world’s best-selling drug will be free from biosimilar competition in the U.S. Biosimilars to AbbVie’s Humira have already hit the market in the EU.

Now, the FDA has approved a biosim, Hadlima, developed by Samsung Bioepis Co and commercialized by Merck and Co. Despite the approval, the drug won’t be rolled out until June 30, 2023 — the launch date negotiated with AbbVie. The FDA has also approved a Humira copycat by Novartis AG.

Hadlima will be released with the same black box statement as Humira, which warns patients about the risk of serious infections and some cancers.

Humira, which treats several inflammatory conditions such as rheumatoid arthritis, psoriasis and more, pulled in nearly $20 billion in sales last year. According to Samsung Bioepis, sales for Hadlima (marketed in the EU as Imraldi and launched in Oct. 2018) reached $47.3 million in the first quarter of 2019 alone.

Read the Reuters report.