Genmab — Maj 2021
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Var det Bulder, der spurgte til suffixet i amivantamab: amivantamab-vmjw? Det er en tilfældig samling af bogstaver, som IKKE må have nogen mening og hvis funktion er at kunne skelne et biosimilært kopi-produkt fra det originale produkt. https://www.centerforbiosimilars.com/view/alphabet-soup-the-story-behind-biosimilar-nonproprietary-name-suffixes
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Og her FDAs skriv "Nonproprietary Naming Guidance", på s.10 står om suffixet. https://www.fda.gov/files/drugs/published/Nonproprietary-Naming-of-Biological-Products-Guidance-for-Industry.pdf
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Og det MÅ IKKE: "•Be false or misleading, such as by making misrepresentations with respect to safety or efficacy•Include numerals and other symbols aside from the hyphen attaching the suffix to the core name•Include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order•Contain or suggest any drug substance name or core name..
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•Look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting)•Look similar to or otherwise connote the name of the license holder•Be too similar to any other FDA-designated nonproprietary name suffix"
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Fra Janssens artikel: Dr. Knoblauch is hopeful that the drug will prove to be an effective treatment for other types of cancer, as well.
“There are several other types of tumors we can explore where one of the same genes that our bispecific binds to is overexpressed,” he says. “I’m looking forward to seeing if there is potential for this drug to help patients with other types of cancers, too.” https://www.jnj.com/innovation/journey-to-fda-approval-non-small-cell-lung-cancer-treatment
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Enig Stroka. Jeg lægger artiklen op i debatten.
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Bibob..Det er utrættelige E L som har lagt den ud via link til Janssens opslag på Twitter. Tak til ham.
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