Biosimilar Race US Lags Behind Europe


Abrilada, developed by Pfizer Inc. (PFE), and a biosimilar version of AbbVie’s Humira, was approved by the FDA on November 15, 2019.

Abrilada is indicated for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis. The drug is the fifth Humira biosimilar to secure the regulatory nod in the U.S.

The patent on Humira expired in Europe in June 2017 and in the U.S. in November 2017.

Humira had total sales of $19.93 billion in 2018. In the third quarter of 2019, sales of Humira were down 3.7% to $4.936 billion.

Abrilada is expected to be launched in the U.S in 2023, as per an agreement with AbbVie.