Shots:
The US FDA has approved Hadlima (biosimilar, adalimumab) for patients suffering from chronic, autoimmune diseases. Hadlima is a citrate-free, high-concentration (100 mg/mL) formulation of Hadlima which will be available in pre-filled syringe and autoinjector options
The approval was based on clinical data from a single-dose study to evaluate the PK, safety, tolerability, and immunogenicity of two formulations of Hadlima (100mg/mL vs 50mg/mL) in 88 healthy volunteers
Hadlima is expected to be available in the US in 2023. Hadlima has also approved in the US as a low-concentration (50mg/mL) formulation in July 2019 and outside the US in multiple markets globally under different brand names
Ref: Businesswire | Image: Samsung Bioepis
