Shots:
- FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vial
- Designation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO receiving Humira continuously or those who alternated between EU Humira & Hadlima; additional clinical data also supportedthe designation
- FDA approved Hadlima’s low-concentration (40mg/0.8mL) in 2019 while its high-concentration version (40mg/0.4mL) was approved in 2022, both as prefilled syringes & autoinjectors
Ref: Businesswire| Image: Samsung Bioepis & Organon| Press Release
Related News:- Teva and Samsung Bioepis Launch Epysqli (Biosimilar, Soliris) in the US
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
