Woodcock said that if a biotech company develops a longer-lasting version of a drug, or otherwise alters an existing molecule to improve efficacy of safety, it would be considered a new molecule, with a new 12-year exclusivity.
This seems like it will open a new bag of worms. Betterbiosimilar.
I'm wondering how they would treat something like Lilly's humanized egfr versus the chimeric cetuximab?
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