Alvotech's AVT06 Biosimilar Candidate Receives Positive EMA News

EMA Confirms Acceptance of Marketing Application for AVT06

Key Takeaways:

• Alvotech's AVT06 biosimilar candidate for Eylea has received marketing application acceptance from the European Medicines Agency (EMA).
• The EMA is responsible for evaluating most biosimilar marketing applications in the EU.
• Acceptance of the marketing application marks a significant milestone in the development of AVT06.

On June 18, 2024, Alvotech (NASDAQ: WEB) announced that the EMA had accepted the marketing application for its AVT06 biosimilar candidate for Eylea.

This acceptance is a major step forward for Alvotech, as it brings the company closer to commercializing AVT06 in the European Union (EU).

The EMA is responsible for evaluating the majority of applications to market biosimilars in the EU. The agency's scientific guidelines on biosimilar medicinal products help ensure that biosimilars are safe and effective.

About AVT06

AVT06 is a biosimilar candidate for Eylea (aflibercept), a drug used to treat wet age-related macular degeneration (AMD) and other eye conditions.

Biosimilars are similar to brand-name drugs but are developed and manufactured by different companies. Biosimilars must meet the same safety and efficacy standards as brand-name drugs, but they are typically available at a lower cost.

There are at least five Eylea biosimilar molecules that are in the final stages of approval. ADVANZ PHARMA recently secured the rights to commercialize Alvotech's biosimilar candidate for Eylea in the EU.

Significance for Alvotech

The acceptance of the marketing application for AVT06 is a significant milestone for Alvotech. The company has a strong track record of developing and commercializing biosimilars, and AVT06 is expected to be a key product for the company.

If approved, AVT06 will be the first biosimilar to Eylea on the market. This could give Alvotech a significant first-mover advantage in the rapidly growing biosimilar market.

Conclusion

The acceptance of the marketing application for AVT06 is a major step forward for Alvotech. The company is now one step closer to commercializing AVT06 in the EU, which could be a significant boost to its revenue and profitability.