Sanofi-Aventis, the makers of the insulin glargine reference product Lantus, has jumped into the biosimilar arena, having received FDA approval on February 14 for an insulin aspart biosimilar. Dubbed Merilog (insulin aspart-szjj), the agent is a rapid-acting insulin whose reference drug is NovoLog.
There are two biosimilars to insulin glargine, the long-acting formulation, and this is the first approval for a rapid-acting human insulin analog. There is relatively little publicly disclosed activity in the insulin pipeline. In fact, recent federal initiatives and pharmaceutical company efforts have limited patient costs of insulin to approximately $30 per month. The existence of several insulin glargine options (including older follow-on products and the biosimilars) has resulted in wholesale acquisition prices uniformly below $100 per 1,000 IU, and in the case of Semglee, one third of this WAC figure. Unfortunately, the biosimilar utilization for glargine lags, with only a 6% marketshare, according to the Samsung Bioepis Biosimilar Market Report.
With far less competition in this drug category, it will be interesting to see whether Sanofi can make a splash. It may be telling that Sanofi did not issue its own press release for the FDA approval of Merilog, nor is it mentioned as part of the company’s pipeline.
In Other Biosimilar News
On February 18, partners Alvotech and Teva announced that their 351(k) filing for AVT06, an aflibercept biosimilar, had been accepted by the FDA. Alvotech also disclosed that it is developing a separate biosimilar candidate (AVT29) for the high-dose version of Eylea (Eylea HD).
The preliminary results of a confirmatory clinical study of AVT06 demonstrated comparable efficacy, safety, and immunogenicity with Eylea in patients with neovascular (wet) age-related macular degeneration. Alvotech is expecting an FDA decision in the fourth quarter of this year.
Five aflibercept biosimilars have already been approved by the FDA, and one by Amgen (Pavblu) has launched.
