Pfizer Gets Positive CHMP Opinion for Ruxience Biosimilar to MabThera
January 31 2020 - 9:48AM
Dow Jones News
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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