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European Medicines Agency confirms acceptance of marketing application for AVT06, a proposed biosimilar of Eylea (aflibercept) Page 1

European Medicines Agency confirms acceptance of marketing application for AVT06, a proposed biosimilar of Eylea (aflibercept) Page 1

  • The approval process is expected to be completed in the third quarter of 2025.

Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacturing of biosimilars for patients worldwide, and Advanz Pharma, a global pharmaceutical company headquartered in the United Kingdom with a strategic focus on specialty, hospital and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). The process to obtain Marketing Authorization could be completed in the third quarter of 2025.

“The EMA acceptance brings us one step closer to making AVT06 available in Europe, which is good news for patients and caregivers,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “The successful development of multiple biosimilar candidates demonstrates how Alvotech is leveraging its end-to-end biosimilar platform to support broader access to affordable biologics.”