Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less. The biosimilar referenced MabThera/Rituxan, originally developed by Swiss pharmaceutical giant Roche. The original drug sells under the brand name MabThera in Europe and Korea, and Rituxan in the United States. "CT-P 10 [a code name for Truxima] is highly similar to U.S.-Rituxan, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between CT-P10 and U.S.-Rituxan in terms of the safety, purity and potency of the product," said the committee in the briefing document. "We welcome the ODAC's recommendation.