Watch out, Remicade. South Korea-based Celltrion is gunning to launch its biosimilar version, Remsima, in the U.S. by the end of this year.
In an interview with The Wall Street Journal, Celltrion Healthcare CEO Stanley Hong said his company will start shipping its version of the anti-inflammatory blockbuster to the U.S. later this year. Pending FDA approval for the product, of course.
The prospect of a Remicade biosim launching in the U.S. seemed several years away until February, when the U.S. Patent and Trademark Office rejected a patent covering the drug till September 2018. J&J has said it will "pursue all available appeals" if necessary to keep its drug protected through that date.
Marketed by Johnson & Johnson ($JNJ) and Merck ($MRK), Remicade brought in $8.3 billion in sales last year, including $5.2 billion in the U.S. In Europe, its sales have started to drop--if only slightly--now that Celltrion and its partner Hospira ($HSP) have begun launching biosimilar versions.
The European market for Remicade biosims illustrates some challenges for Celltrion and its ilk--and could provide some comfort to J&J and Merck if Remsima does launch in the U.S later this year. Uptake in the E.U. has been slow, partly because doctors are wary of biosimilars. Norway is funding a head-to-head trial, pitting Celltrion's Remsima against the branded med, hoping to show physicians that biosimilars are viable alternatives.
Meanwhile, Novartis' ($NVS) Sandoz unit is working to get its Neupogen knockoff Zarxio on the market in the U.S. After winning approval from the FDA last month, Sandoz has been jousting with Amgen ($AMGN) in court, in a landmark case that could better define a pathway to market for U.S. biosims. Amgen tried for an injunction against the Sandoz launch--and failed--but a potential patent fight remains. Amgen also petitioned the FDA to block Sandoz's version, but the agency rejected the plea.
- read the WSJ interview
Special Reports: The best-selling drugs of 2013 - Remicade
Editor's note: A previous version of this story identified Stanley Hong as CEO of Celltrion. He is in fact CEO of Celltrion Healthcare.