Samsung Bioepis launches Remicade biosmiliar
Samsung Bioepis launches U.S. sales of Remicade biosmiliar
SEOUL (Reuters) — South Korea’s Samsung Bioepis Co Ltd said it started U.S sales of its copy of Johnson & Johnson’s rheumatoid arthritis drug Remicade on Monday — a move set to further undermine sales of the U.S. firm’s top-selling drug.
It is the second cheaper biosimilar version of Remicade to be sold after Pfizer Inc’s Inflectra. Remicade had U.S. sales of $4.8 billion last year, but January-June sales fell 8.2 percent from a year earlier to $2.2 billion on its new competition.
A Johnson & Johnson unit, Janssen Biotech Inc, has sought a preliminary or permanent U.S. court injunction to block Bioepis’s version, arguing that the South Korean firm violated three of its patents. A hearing for the lawsuit has yet to be scheduled.
“We are confident we do not infringe on Janssen’s patents,” Samsung Bioepis spokesman Mingi Hyun told Reuters in a statement.
Samsung Bioepis, an unlisted unit of contract drug manufacturer Samsung BioLogics Co Ltd, received U.S regulatory approval to launch its biosimilar, Renflexis, in April. Biosimilars are lower-cost versions of complex biotech drugs, and Bioepis has focused on developing copies of some of the world’s top selling drugs.
Drugmakers in the past have pushed ahead with sales of products that were subject to patent litigation, but they can face heavy penalties if they lose in court.
A U.S. judge in 2013 awarded AstraZeneca Plc $76 million in damages from generic drug maker Apotex for patent infringement for AstraZeneca’s heartburn drug Prilosec, or the equivalent of 50 percent of profits generated during the three-and-a-half-year period Apotex sold a generic version of Prilosec.
Reporting by Se Young Lee; Editing by Edwina Gibbs