By Colin Kellaher

 

Pfizer Inc. (PFE) on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Ruxience, a potential biosimilar to Roche Holdings AG's (ROG.EB) cancer drug MabThera.

The New York drug maker said Ruxience is a monoclonal antibody for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

The European Commission, which generally follows the CHMP's recommendations, is expected to make a regulatory decision in the first half of the year, Pfizer said, adding that Ruxience could become its fifth oncology biosimilar to gain regulatory approval in Europe.

Biosimilars are near-copies of biologic drugs, such as MabThera, that are made from living cells and are analogous to generic copies of traditional pill-form medicines.

Pfizer received U.S. Food and Drug Administration approval for Ruxience in July 2019.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

January 31, 2020 09:33 ET (14:33 GMT)

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