Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

FDA approves Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab)

Oct 15, 2021

Boehringer Ingelheim announced that FDA has approved Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab).   Cyltezo® is a 50 mg/mL “citrate free” (ie acetate buffered) product, and the “interchangeable” designation will be limited to only some of the Humira® products, unless FDA responds favourably to the citizen petition lodged by Boehringer Ingelheim in December 2020 requesting FDA to interpret the term “strength” in legislation in section 351(k) of the Public Health Service Act (42 U.S.C. 262(k) in a manner which would extend BI’s interchangeability designation to all formulations delivering the same amount of active (irrespective of concentration).  The FDA stated in a May 2021 interim response that it has been unable to made a decision on the CP to date “because it raises complex issues requiring extensive review and analysis by Agency officials”.