Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity
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.
You may also be interested in...
In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.
Amid several new and updated draft guidance documents and the potential approach of the first approval, interchangeability continues to be a buzzword in US biosimilars.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.
A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.