The first biosimilar versions of a monoclonal antibody have received a positive opinion from the European Medicines Agency (EMA), paving the way for cheaper versions of expensive biologic drugs to enter the market. On June 28, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended Inflectra and Remsima, both containing infliximab, similar to the biological therapy best-seller Remicade, made by Merck of Whitehouse Station, New Jersey, and marketing partner J&J of New Brunswick, New Jersey. Infliximab is a chimeric human-murine IgG that neutralizes tumor necrosis factor alpha, an inflammation-promoting protein. The antibody copies are produced by Celltrion of Incheon City, South Korea, and Hospira, of Lake Forest, Illinois. The CHMP recommended Inflectra and Remsima for the same indications as Remicade: rheumatoid arthritis, Crohn's disease and psoriasis. Once the patent for Remicade expires in the EU next August, biosimilar sales are expected to make a severe dent in the $2 billion in revenues from sales of Remicade in Europe. In three to four years, Remicade biosimilars could capture about 40% of the EU market at about a 40% price reduction, says Bernstein analyst Ronny Gal in New York. Twelve biosimilars have been authorized in the EU since 2006, but Inflectra is the first structurally complex biologic. “We are not expecting that their approval will open 'floodgates,' but rather that the steady stream of applications for biosimilars will continue,” says Martin Harvey Allchurch, EMA's head of communications. Celltrion has eight different monoclonal antibodies currently in development.