Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive the US FDA’s Approval for Chronic Autoimmune Diseases
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
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
