We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer Gets FDA Approval for Biosimilar of AbbVie's Humira
Read MoreHide Full Article
Pfizer, Inc. (PFE - Free Report) announced that the FDA granted approval to its biosimilar version of AbbVie’s (ABBV - Free Report) 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 - Free Report) 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 - Free Report) 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.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replac-ed by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Pfizer Gets FDA Approval for Biosimilar of AbbVie's Humira
Pfizer, Inc. (PFE - Free Report) announced that the FDA granted approval to its biosimilar version of AbbVie’s (ABBV - Free Report) 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 - Free Report) 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 - Free Report) 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.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replac-ed by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>