Coherus Secures FDA Approval on Yusimry™, Its Adalimumab Biosimilar

On December 20, Coherus Biosciences announced that the Food and Drug Administration approved Yusimry (adalimumab-aqvh). This is Coherus’ second biosimilar approval.

In 2017, Coherus completed a randomized, controlled phase 3 study involving 545 patients with moderate-to-severe plaque psoriasis, comparing the biosimilar to the reference product. In addition, the company conducted a pharmacokinetic investigation that confirmed similarity to Humira® in healthy volunteers.

Formerly known as CHS-1420, Yusimry has received approval for the following Humira indications:

  • Plaque psoriasis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Juvenile idiopathic arthritis
  • Ankylosing spondylitis
  • Crohn’s disease
  • Ulcerative colitis

In its press release, Coherus CEO Denny Lanfear stated, “Growth and diversification of our biosimilar portfolio is a high priority for Coherus—first and foremost as it enables greater patient access to important medicines—and because revenue from these products will fund the continued investment in our innovative pipeline programs that will drive our future growth.”

This is the seventh approval of an adalimumab biosimilar. According to Coherus, it is scheduled to launch no earlier than July 1, 2023. Yusimry is a 50-mg/mL formulation.

The next adalimumab in line for FDA approval is Celltrion’s CT-P17, which filed in November 2020. This agent is a bit overdue for an FDA decision, but no word has been issued regarding its status. Recently, the FDA deferred its decision on Alvotech’s AVT02 because of delays in completing its factory inspection. The same issue may be at play here. Both products are approved for use in the European Union.

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