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Pfizer Gets FDA Approval for Biosimilar of AbbVie's Humira

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Pfizer, Inc. PFE announced that the FDA granted approval to its biosimilar version of AbbVie’s ABBV blockbuster drug Humira for multiple inflammatory conditions. The biosimilar will be marketed by the trade name Abrilada.

Pfizer has a non-exclusive licensing deal with AbbVie under which it can launch Abrilada in the United States on Nov 20, 2023. In the EU, Pfizer can launch Humira biosimilar when it gets an approval from the European Medicines Agency.

The FDA nod was based on a comprehensive data package, which included results from the REFLECTIONS B538-02 comparative study. The study found no clinically meaningful differences in the efficacy, safety or immunogenicity of Abrilada to AbbVie’s branded product.

Pfizer’s shares have declined 14.8% this year so far versus its industry’s increase of 4.7%.



The approval of Humira biosimilar is the fourth U.S. nod to a biosimilar product for Pfizer in 2019. Earlier this year, the company’s biosimilar versions of Roche’s RHHBY cancer drugs Herceptin (trade name: Trazimera), Avastin (trade name: Zirabev) and Rituxan (trade name: Ruxience) were approved by the FDA. Biosimilars of Herceptin and Avastin are already approved in the EU while that of Rituxan is under review in the region. In Europe and the United States, Pfizer also markets biosimilar versions of Amgen’s AMGN drugs Neupogen and Epogen and Merck/J&J’s Remicade.

Humira is AbbVie’s key top-line driver. Several companies made biosimilar versions of Humira. Including Pfizer, AbbVie has settled with nine manufacturers, per which,       Humira biosimilars are expected to be launched in the United States during 2023. However, Humira biosimilars are already launched in Europe.

Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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