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29 Jan 2020

Pfizer launched Zirabev, Ruxience, Trazimera biosimilar in US

Pfizer has launched three biosimilars in the U.S. market. Pfizer has priced these biosimilars aggressively to get quick market share.

Zirabev Biosimilar

  • Zirabev (bevacizumab-bvzr), a biosimilar to Roche’s Avastin, was launched on December 31, 2019, at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, a 23% discount compared to the WAC of the branded product.
  • The biosimilar was approved in June 2019 by the FDA for the treatment of metastatic colorectal cancer, recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.
  • It also earned the European Commission’s approval in February 2019 after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in December 2018.
  • Last November, the FDA accepted for review SB8, a proposed bevacizumab biosimilar from Samsung Bioepis.

Ruxience Biosimilar by Pfizer

  • Ruxience (rituximab-pvvr), a biosimilar to Roche’s Rituxan, was launched today at a WAC of $71.68 per 10 mg, a 24% discount versus the branded version.
  • The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.

Trazimera Biosimilar by Pfizer

  • Trazimera (trastuzumab-qyyp), a biosimilar to Roche’s Herceptin, will be available on February 15 at a WAC of $80.74 per 10 mg, a 22% discount versus the branded product.
  • The FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between TRAZIMERA and the originator product.

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