Second Biosimilar Gets FDA Nod

Inflectra (infliximab-dyyb) approved to treat several conditions that affect the immune system

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(RxWiki News) The US Food and Drug Administration (FDA) has approved the second-ever biosimilar, and it's meant to treat multiple conditions that affect the immune system.

That drug is Inflectra (infliximab-dyyb). The FDA approved it for the following conditions:

  • Moderate to severe active Crohn’s disease
  • Moderate to severe active ulcerative colitis
  • Moderate to severe active rheumatoid arthritis (given with methotrexate)
  • Active ankylosing spondylitis (arthritis of the spine)
  • Active psoriatic arthritis
  • Chronic, severe plaque psoriasis

According to the FDA, a biosimilar product is a biological product that is highly similar to a biological product that has already been approved. This product is known as a reference product.

In this case, the reference product is Janssen Biotech’s Remicade (infliximab). In addition, Inflectra had to show there was not a clinically meaningful difference in safety and effectiveness when compared to Remicade.

Inflectra carries a boxed warning noting an increased risk of serious infections. The manufacturer of Inflectra recommends patients notify their doctors at the first sign of an infection during Inflectra's administration or after receiving Inflectra. Signs of infection include fever, flu-like symptoms, extreme tiredness, cough and warm, red or painful skin.

Last Updated:
April 7, 2016