FDA Offers Clarity On Biosimilar Interchangeability
Guidance Provides Draft Q&As On Applications And Labeling
A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.
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Amid several new and updated draft guidance documents and the potential approach of the first approval, interchangeability continues to be a buzzword in US biosimilars. AbbVie has projected that two Humira (adalimumab) biosimilars will hold the designation when they launch in 2023.
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.