Pfizer's Biosimilar Ruxience Gets EU Regulatory Backing
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that the European Commission approve Pfizer's (NYSE: PFE) drug Ruxience, a biosimilar to MabThera, which to Roche (OTC: RHHBY) and Biogen (NASDAQ: BIIB) sell in the U.S. as Rituxan.
CHMP's positive opinion was based on a clinical trial, dubbed Reflections B3281006, which compared Ruxience to the branded biologic drug MabThera in patients with a specific type of follicular lymphoma. Both drugs produced similar overall response rates.
Biologics are large-molecule drugs that are produced using living organisms, as opposed to via chemical processes like conventional, small-molecule medications. This difference in how they're manufactured means that while another company may be able to develop a biologic that does essentially the same thing as a previously approved drug, that new version -- the biosimilar -- will not be not quite the same as the original -- thus the "similar" in the name.
Source Fool.com
