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Pfizer's Mertoviline generic Ruxience, approved by the European Union

 Last Update: 2020-05-29
 Source: Internet
 Author: User

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Pfizer has received EU approval for the biosimilar Ruxience (rituximab) biosimilar to CD20 monomera (rituxira, mabThera, rituximab)approved for the use of Ruxience for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granuloma with polyvascularitis (GPA) and micropolyvasitis (MPA) and common herpes (PV)the decision was based on a series of data on the biological similarity of Ruxience and MabThera, including results from a clinical comparative study of REFLECTIONS B3281006, which evaluated Ruxience's efficacy, safety, immunoogenics, pharmacokinetics, and pharmacodynamic parametersThe data showed that Ruxience "had no clinically significant difference sable in CD20-positive, low tumor-loaded follicles patients with the safety or efficacy of MabThera." Masum Hossain, regional president ofPfizer Oncology International Development Market, added: "Biosimilars like Ruxience have similar safety and efficacy to the original product and can significantly reduce healthcare costs"

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