On August 12, Sandoz announced that it had received FDA approval for its latest biosimilar: Enzeevu (aflibercept-abzu).
This FDA approval includes the indication for wet age-related macular degeneration (or neovascular AMD [nAMD]). In Sandoz’s press release, 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.”
However, Enzeevu is not currently indicated for Eylea®’s additional indications (e.g., macular edema, following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, etc). Its biosimilar competition, including Formycon’s Ahzantive™, Biocon’s Vesafili™, and Samsung Bioepis’ Opuviz™ are approved for the wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema and diabetic retinopathy indications. It is unknown whether this “skinny label” will be a competitive disadvantage for Sandoz.
Sandoz enters a drug category with brisk competition, including three other manufacturers with approved aflibercept biosimilar products, as well as another with a pending FDA decision. Enzeevu has been given a provisional interchangeability designation, following the approval of two other interchangeable products. Yet this designation has little meaning for the aflibercept category, as interchangeability applies only to automatic substitution by pharmacies. This agent, like ranibizumab, is primarily a buy-and-bill product—purchased directly by the physician’s office and reimbursed by the payer.
With the approval of Enzeevu, Sandoz has an ophthalmology franchise that includes its purchase of Coherus’ Cimerli® (ranibizumab) and a biosimilar version of bevacizumab that is yet to be marketed (which may be compounded for use for ophthalmologic indications).
