The U.S. Food and Drug Administration (FDA) has given the green light to Enzeevu, a new biosimilar product developed by Sandoz. The approval includes both the 2 mg vial kit and the prefilled syringe of Enzeevu, which is designed for intravitreal injection. This treatment targets neovascular age-related macular degeneration (AMD), a serious condition that leads to vision loss due to abnormal blood vessel growth in the retina.
Enzeevu (aflibercept-abzv) is specifically indicated for both improving and maintaining visual acuity in patients suffering from neovascular AMD. This approval is significant because it offers an alternative to existing treatments, particularly for those who have been relying on the brand-name drug Eylea (aflibercept, marketed by Regeneron). Notably, the FDA has also provisionally determined that Enzeevu is interchangeable with Eylea. This interchangeability designation means that Enzeevu can be used as a substitute for Eylea in the treatment of neovascular AMD, which could enhance patient access to effective therapy options.
The FDA’s approval of Enzeevu is based on a robust set of clinical data, including findings from the Mylight study, which provided substantial evidence supporting the efficacy and safety of the biosimilar. In addition to clinical trial results, the approval was bolstered by comprehensive analytical and preclinical in vitro study data. This extensive research helped confirm that Enzeevu meets the stringent standards required for FDA approval and reassured regulators of its equivalency to the reference product, Eylea.
Claire D’Abreu-Hayling, the Chief Scientific Officer at Sandoz, highlighted the importance of this approval in a recent press release. She emphasized that the U.S. approval of Enzeevu represents a major milestone in Sandoz’s ongoing efforts to improve the quality of life for patients affected by neovascular AMD, a condition that currently has no cure. The introduction of Enzeevu provides a new, potentially more affordable option for managing this challenging disease, which affects millions of people worldwide.
The FDA’s decision marks a significant advancement in the treatment landscape for neovascular AMD. By offering a biosimilar alternative to Eylea, Enzeevu has the potential to increase competition in the market, which could lead to more accessible and cost-effective treatment options for patients. This approval not only underscores the progress in biosimilar development but also reflects the ongoing commitment to enhancing patient care through innovative therapeutic solutions.