Despite the daunting challenges, manufacturers believe that, even with these stringent requirements (which are as equally demanding in Europe as in the U.S.), the costs of developing and bringing to market a biosimilar would be far less than the cost of developing a novel agent. The first test of this hypothesis is about to start. In June 2013, the European Medicines Agency approved the marketing of an infliximab biosimilar, Remsima. This drug is manufactured in South Korea by Celltrion. It is expected to reach the U.S. market following the expiration of the infliximab patent.
Dr. Strand is clinical professor, adjunct, in the division of immunology/rheumatology at Stanford University in Stanford, Calif. She is an independent biopharmaceutical consultant in clinical development and has consulted for: Abbvie, Amgen Corporation, AstraZeneca, BiogenIdec, BMS, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB. Dr. Brasington is professor and head of the fellowship program at Washington University in St. Louis.
