Remicade Biosimilars: Samsung Looks To Follow Celltrion's Footsteps
This article was originally published in The Pink Sheet Daily
351(k) application relies on data extrapolation from Phase III trial in rheumatoid arthritis to support approval across infliximab's indications, including inflammatory bowel disease.
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The latest drug development news and highlights from our US FDA Performance Tracker.
The big pharma has five biosimilars in Phase III development with its partner Samsung Bioepis, and expects to file them for regulatory approval in 2015 and 2016.
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.