REG-Alvotech and Advanz Pharma announce first known regulatory submission worldwide for proposed biosimilar to Eylea® 8 mg
Globe Newswire•14/10/2026•04:30 ET
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Key Highlights
- ➤AVT29 submitted to EMA as the first known worldwide Eylea 8 mg biosimilar application
- ➤Mynzepli® received European Commission approval in August 2025 for Eylea 2 mg biosimilarity
- ➤Eylea 8 mg represented approximately 57% of combined global sales in Q2 2026
- ➤High-dose formulation potentially extends treatment intervals to 16 weeks for certain patients
- ➤Advanz Pharma holds exclusive European commercialization rights, except semi-exclusive Germany and France
Expert Statements
Lisa Graver, Chief Executive Officer of Alvotech
“To our knowledge, this is the first regulatory submission anywhere in the world for a proposed biosimilar to Eylea 8 mg. This is an important achievement for Alvotech and demonstrates the strength of our in-house development capabilities”
Lisa Graver, Chief Executive Officer of Alvotech
“We recognized early the potential of high-dose aflibercept and invested in developing both the 2 mg and 8 mg formulations. Building on the European approval of Mynzepli, this milestone positions us at the forefront of the next wave of aflibercept biosimilars and reflects our commitment to broadening access to high-quality biologic medicines.”
Steffen Wagner, Chief Executive Officer of Advanz Pharma
“This submission represents an important milestone in our partnership with Alvotech and our shared commitment to improving access to high-quality, affordable medicines. Following the European approval of Mynzepli, we are pleased to be advancing a high-dose formulation that could offer additional treatment options for patients and healthcare professionals across Europe.”
AVT29 submitted to the European Medicines Agency as a line extension to the existing marketing authorization for Mynzepli® (aflibercept 2 mg)
High-dose aflibercept offers the potential to reduce treatment frequency for patients with retinal diseases
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