Draft Guidance on Biosimilar Labeling

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA released a draft guidance in March 2016 on labeling of biosimilar products. The guidance explains: ● labeling to account for differences in administration, storage or safety information ● when to use the biosimilar name, the reference product’s pro- prietary name, and the “core name” of the product, and ● cases where biosimilars are approved for fewer indications than the reference product.
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