Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles
First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.
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A claim that RT002's duration of efficacy surpasses the leading neurotoxin – Allergan's blockbuster Botox – will be put to the test when Revance seeks US FDA approval to treat frown lines in the first half of this year. The company's Botox biosimilar with Mylan also could move forward in 2019.
One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.
Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing, while Amgen's Avastin biosimilar could be template for other products.