Big Molecule Watch
April 3, 2020

Rituximab Biosimilar Updates from Europe


We previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP).  In particular, the EMA reported that these applications were withdrawn after the agency had evaluated the company’s responses to EMA’s questions.  The EMA stated that, based on Mabion’s replies, it was “concerned that biosimilarity between Rituximab Mabion and the reference medicine MabThera had not been fully established,” and that the  “Agency also had concerns about the manufacturing process and the system for ensuring reliable quality of the medicine.”   Relatedly, on March 30, Mabion announced the withdrawal of its rituximab applications from the EMA.  In its announcement, Mabion attributed the withdrawal to a change in regulatory strategy for registration with the EMA.  Specifically, Mabion stated that the withdrawal of the applications concluded “the existing registration procedure initially based on a two-step strategy” comprising obtaining small-scale marketing authorization followed by an application for a large-scale manufacturing process.  Mabion stated that due to its “goal to register a product based on a commercially attractive large-scale quality process,” the application for the small-scale process was withdrawn.


On April 2, Pfizer announced that the European Commission (EC) approved its rituximab biosimilar, RUXIENCE, for the treatment of non-hodgkins lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).  According to Pfizer, this approval is based on data that includes results from the REFLECTIONS B3281006 clinical comparative study that found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma, and follows the positive recommendation from CHMP in January 2020.  RUXIENCE was recently made available to adult patients in the United States for the same indications and also launched in Japan in January 2020.


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