FDA approves Alvotech and Teva's SELARSDI for new indications [Yahoo! Finance]
Alvotech (ALVO)
Company Research
Source: Yahoo! Finance
SELARSDI, a human monoclonal antibody, targets the p40 protein found in interleukin (IL)-12 and IL-23 cytokines - key in immune-mediated diseases. It is developed and produced by Alvotech using Sp2/0 cells and a continuous perfusion process, mirroring the production of Johnson & Johnson (J&J)'s Stelara. This marks a significant step for SELARSDI, aligning its indications with those of the reference product Stelara. It is expected to launch in the first quarter of 2025 in the US. Alvotech chairman and CEO Robert Wessman stated: “We welcome this step which is fully in line with our plan to align the SELARSDI label with the indications of the reference product before launch next year. “We are looking forward to the US launch, after very successful launches of the first biosimilar ustekinumab in Canada, Japan and Europe.” Alvotech and Teva established a strategic partnership in August 2020 to exclusively commercialise five biosimilar product candidates, including SELARSDI. Th
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ALVO
News
- Alvotech's Position In The Coming Biosimilar Gold Rush [Seeking Alpha]Seeking Alpha
- Alvotech (ALVO) Q3 2024 Earnings Call Highlights: Record Revenue Growth and Strategic Advancements [Yahoo! Finance]Yahoo! Finance
- Alvotech (ALVO) Q3 Earnings and Revenues Beat Estimates [Yahoo! Finance]Yahoo! Finance
- Alvotech Reports Financial Results for the First Nine Months of 2024 [Yahoo! Finance]Yahoo! Finance
- Alvotech Reports Financial Results for the First Nine Months of 2024GlobeNewswire
ALVO
Earnings
- 5/21/24 - Miss
ALVO
Sec Filings
- 11/13/24 - Form 6-K
- 11/6/24 - Form SC
- 11/4/24 - Form 6-K
- ALVO's page on the SEC website