Sandoz Receives US FDA Nod for Enzeevu To improve Visual Acuity

The US FDA has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection by Sandoz, the leading company in generic and biosimilar medicines worldwide. Enzeevu is recommended for enhancing and preserving vision in individuals with neovascular age-related macular degeneration (nAMD). Additionally, the FDA has tentatively decided that Enzeevu can be used interchangeably with the reference medication due to its unexpired exclusivity for being one of the first interchangeable biosimilar products.

Claire D’Abreu-Hayling, chief scientific officer, Sandoz, said: “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”

Enzeevu is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements. nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.

Jeff Todd, J.D., president and CEO of Prevent Blindness, said: “As sight disappears, so may a person’s connection to the world. We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable."