Pfizer Reaches Milestone: FDA Approves 25th Biosimilar in US

Pfizer announced November 18th that the biosimilar licensing application (BLA) for its adalimumab biosimilar was approved by the Food and Drug Administration (FDA). The drug will be marketed under the name Abrilada™ (adalimumab-afzb) in November 2023, according to the terms of a licensing agreement with AbbVie.   

According to Pfizer, the drug was approved for the following indications:

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

This represents a subset of reference product Humira®’s indications (though it includes most of the major disorders).

Pfizer’s Global President, Inflammation and Immunology, Richard Blackburn, said in a press release: “Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients.”

Abrilada’s approval is the 25th biosimilar to be licensed in the US, and fifth adalimumab approval. This will place Abrilada as the seventh adalimumab biosimilar to launch in 2023, assuming all of the manufacturers signing licensing agreements have gained approval by that time.

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