Switzerland-based Novartis (NYSE: NVS) subsidiary Sandoz (SWX: SDZ) has announced that a Phase III confirmatory trial for its biosimilar version of Bayer’s (ETR: BAYN) Eylea/Wetlia (aflibercept) has successfully reached its primary efficacy endpoint in neovascular (wet) age-related macular degeneration (nAMD). The study demonstrated that Sandoz’s biosimilar product showed no clinically meaningful difference compared to Bayer’s originator in terms of safety, immunogenicity, and pharmacokinetics.
Positive Results Lead to Planned Filings in EU and US
Encouraged by the positive results, Sandoz is now planning to file its biosimilar aflibercept for regulatory review in the European Union (EU) and the United States. This move is a strategic step towards expanding access to an affordable alternative for patients suffering from nAMD.
Eylea’s Blockbuster Status and Market Impact
According to Fineline Info & Tech data, Eylea was one of Bayer’s top-selling drugs last year, contributing EUR 3.2 billion (USD 3.4 billion) in global sales after a 9.2% year-on-year (YOY) growth. The success of Sandoz’s biosimilar trial could potentially impact the market dynamics for nAMD treatments, offering a more cost-effective option for this prevalent condition.-Fineline Info & Tech
