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From Alvotech Submits Biosimilar Application for Retinal Disease Treatment to EMA

How could Alvotech's regulatory application for a biosimilar affect Incyte?

Possible What happens if… A possibility worth considering, not a forecast.

Alvotech's biosimilar submission could increase competition in retinal disease treatment Alvotech submitted a regulatory application to the European Medicines Agency (EMA) for AVT29, a proposed biosimilar to Eylea® 8 mg, which is used to treat certain retinal diseases. If this application progresses and AVT29 receives approval, it would introduce a new, potentially more affordable treatment option into the European market. Since Incyte is identified as a competitor within the healthcare market, the introduction of a new biosimilar could increase market competition, potentially impacting Incyte's market share and revenue in the relevant therapeutic area.

Reported by 1 independent outlet Written Wednesday
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The facts so far

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  • Alvotech submitted a regulatory application to the European Medicines Agency (EMA) for AVT29.manilatimes.net
  • AVT29 is a proposed biosimilar to Eylea® 8 mg, which is used to treat retinal diseases.manilatimes.net
  • The application was submitted as a line extension to the existing European marketing authorization for Mynzepli®.manilatimes.net
  • The 8mg formulation of Eylea® accounted for approximately 57% of combined global Eylea® 2mg and 8mg sales by value in the second quarter of 2026.manilatimes.net

Why it matters

The biosimilar market is highly competitive, and the introduction of a new, potentially lower-cost option like AVT29 could significantly alter market dynamics for drugs treating retinal diseases. For Incyte, which operates in the broader healthcare market, increased competition in a specific therapeutic area represents a direct threat to established revenue streams and market share.

This submission follows Alvotech's successful approval of Mynzepli® as a biosimilar to Eylea® 2 mg in Europe. Alvotech has positioned itself as a leader in aflibercept biosimilars, and its strategic partnerships, such as the one with Advanz Pharma, aim to broaden access to these high-quality biologic medicines across Europe.

What we don't know yet

  • Will the EMA approve AVT29, and what will the final pricing be?
  • How quickly will AVT29 reach commercial availability in Europe?

What would change this answer

The EMA grants a positive regulatory opinion on AVT29.The effect on Incyte would become stronger and more certain, as market entry would be imminent.
The EMA rejects the application for AVT29.The competitive pressure on Incyte from this specific product would fade, and the market would remain stable.

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Questions worth asking

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  • About CHMP

    Since the application was submitted to the EMA, which specific committee is responsible for reviewing AVT29's biosimilar status?

  • About FDA Administration

    If AVT29 receives approval in Europe, what is the likelihood or timeline for Alvotech to seek approval from the FDA?

  • About Marketing Authorization

    How does the process of extending a marketing authorization for a line extension differ from seeking a new authorization for a biosimilar?

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The full eventAlvotech Submits Biosimilar Application for Retinal Disease Treatment to EMA Everything aboutIncyte

Brind's analysis is written by AI from the reporting linked above and can be wrong. This explainer is a possibility worth considering, not a forecast: steps marked as Brind's reasoning are not stated in the reporting. It is not investment advice; do your own research.