Alvotech (ALVO) and Teva Pharmaceutical Industries' (TEVA) US affiliate said Tuesday that the US Food and Drug Administration has agreed to review a Biologics License Application for AVT06, Alvotech's proposed biosimilar to Regeneron Pharmaceuticals' (REGN) Eylea, as a potential treatment for eye disorders.
The companies said they anticipate Q4 regulatory approval for the drug.
The FDA review follows 2024 results from a clinical study of AVT06 which met its primary endpoint of therapeutic equivalence and comparable safety Eylea, the companies said.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.