Alvotech Reports the US FDA’s Acceptance of BLA for Review of ATV02 (biosimilar, adalimumab) to Treat Chronic Plaque Psoriasis
Shots:
- The US FDA has accepted the BLA for ATV02 (100mg/mL) including new data to support interchangeability for Alvotech’s adalimumab biosimilar referencing Humira. The US FDA’s decision is expected in Dec 2022
- The results from the (AVT02-GL-302) study evaluate the PK, efficacy, safety & immunogenicity of AVT02 in 568 patients which showed bioequivalence of repeated switches b/w Humira & AVT02 and the biosimilar compared with Humira without switching
- Humira biosimilars are expected to be launched in the US in Jan 2023 while AVT02 has received approval in the EU, Canada & UK & will be marketed as Simlandi. Alvotech entered into a commercialization agreement with Teva to commercialize AVT02 in the US
Ref: Businesswire | Image: Alvotech
Click here to read the full press release
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.
