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Biotech Stocks Facing FDA Decision In December 2021

Coherus BioSciences
Coherus BioSciences

Coherus BioSciences Inc (CHRS) has sought FDA approval for CHS-1420, a biosimilar candidate referencing AbbVie’s Humira, and a decision is expected to be announced in December.

Humira is a recombinant human IgGl monoclonal antibody approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, hidradenitis suppurativa, and certain types of uveitis.

Already 6 biosimilars to Humira have been approved - Amgen’s Amjevita, Boehringer Ingelheim’s Cyltezo, Sandoz’s Hyrimoz, Samsung Bioepis’ Hadlima, Pfizer’s Abrilada, and Mylan/Fujifilm Kyowa Kirin Biologics’ Hulio.

If approved, CHS-1420 will be joining the list as the seventh biosimilar to Humira.

As per an agreement with AbbVie, all the approved biosimilars to Humira will be launched only after July 31, 2023.

CHRS closed Friday’s trading at $18.37, down 2.96%