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Biosimilars: What's in a Name?
BioPharm International speaks to the United States Pharmacopeial Convention to find out who will truly have the final say when it comes to biosimilar nomenclature.
There is still some uncertainty surrounding whether a biosimilar will share the same compendial identity-or biological product monograph-as its reference product. It has been reported that FDA determined that the the United States Pharmacopeial Convention’s (USP’s) monograph for filgrastim does not apply to the first-ever approved biosimilar product, Zarxio (filgrastim-sndz). In this BioPharm International article, Randi Hernandez speaks to USP to find out more about how the naming process for a drug occurs and who truly will have the final say when it comes to biosimilar nomenclature.
http://www.biopharminternational.com/what-s-name-biosimilars-lot
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
