Alvotech and Teva Reports the US FDA’s Acceptance of BLA for Review of AVT04, a Proposed Biosimilar to Stelara (ustekinumab)
Shots:
- A BLA for AVT04, a proposed biosimilar to Stelara (ustekinumab) has been accepted for review by the US FDA for the treatment of a variety of inflammatory conditions. The US FDA’s review is expected to be completed in H2’23
- Under the Aug 2020 agreement, Alvotech and Teva collaborated for the exclusive commercialization in the US of five biosimilar product candidates incl. an adalimumab biosimilar (AVT02) referencing Humira
- AVT02 is currently under the US FDA’s review and is expected to enter the US market in July 2023, along with 6 other adalimumab biosimilars. In May 2022, Alvotech highlighted the positive results from a PK similarity study for AVT04
Ref: Businesswire | Image: Alvotech
Related News:- Alvotech Reports Results of AVT04, a Proposed Biosimilar to Stelara in (AVT04-GL-101) PK Study for the Treatment of Plaque Psoriasis
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.
