Celltrion’s Remicade Biosimilar Takes U.S. Regulatory Shortcuts
This article was originally published in PharmAsia News
After just one year of working with the U.S FDA, the South Korean company is positioning itself to launch its first monoclonal antibody biosimilar in the U.S. market.
You may also be interested in...
The agency says it expects to receive three biosimilar marketing applications in fiscal year 2014 and another seven in FY 2015, as well as much more in program revenue.
351(k) application seeks approval for full array of indications carried by Amgen’s Neupogen, which could give Sandoz product a competitive advantage over Teva’s marketed tbo-filgrastim, approved as traditional BLA.
Leading players in the biosimilars realm discuss possible roadblocks to development, the battle over naming and substitution, and strategies to avoid the patent litigation dance.