Pfizer’s Rituxan Biosimilar Meets Endpoint in Phase III
Pfizer Inc. PFE announced positive top-line results from a phase III comparative study, evaluating PF-05280586, the company’s biosimilar version of Roche’s RHHBY blockbuster leukemia drug Rituxan/Mabthera (rituximab).
Notably, Rituxan is approved for treating blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia as well as immunological diseases like rheumatoid arthritis.
Shares of Pfizer have gained 18.5% in a year’s time, underperforming the industry’s rally of 23.5%.
The phase III REFLECTION B3281006 study was designed to compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 compared with Rituxan. The study met its primary endpoint demonstrating equivalence in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden and follicular lymphoma.
This marks Pfizer’s fifth proposed biosimilar monoclonal antibody (mAb), showing positive trial results.
Significantly, Pfizer’s biosimilar capabilities were substantially boosted by the acquisition of Hospira in 2015. In December 2017, the company launched Ixifi, the second biosimilar version of Johnson & Johnson JNJ/Merck & Co., Inc.’s MRK blockbuster drug, Remicade, in the United States.
We remind investors that Pfizer is evaluating 14 biosimilar molecules in various developmental stages. Incidentally, biosimilar products in late-stage development include the biosimilar versions of Roche’s Avastin and AbbVie’s Humira. Also, Herceptin’s biosimilar version is under review in the United States as well as the EU.
Importantly, Novartis and Teva filed regulatory applications last year in the United States for the biosimilar version of Rituxan in September and June respectively.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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