Celltrion’s Yuflyma (biosimilar, adalimumab) Receives the US FDA’s Approval for Multiple Indications
Shots:
- The US FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira for the treatment of 8 conditions: RA, JIA, PsA, AS, CD, UC, PsO, and HS. Yuflyma is a high-concentration (100mg/mL) & a citrate-free adalimumab biosimilar
- The approval was based on a comprehensive data package of preclinical, clinical, and analytical studies which showed that the biosimilar and reference products were similar with regard to efficacy, safety, PK, and immunogenicity after 24wks. and 52wks. of treatment
- Yuflyma is supplied as 40mg/0.4mL in single-dose prefilled autoinjectors (Yuflyma AI) and single-dose prefilled syringes. The product is expected to be available in July 2023 in the US
Ref: Businesswire | Image: Celltrion
Related News:- Celltrion Launches Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Disease in Canada
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
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.
