(CercleFinance.com) – Sandoz, a subsidiary of Novartis in the process of being spun off, announces the positive results of the Phase III efficacy and safety confirmation study MYLIGHT for its aflibercept biosimilar, intended for patients with wet macular degeneration.
The study met its primary efficacy endpoint, showing therapeutic equivalence in the mean change in best corrected visual acuity (BCVA) between the biosimilar and its reference patented medicine, Eylea.
“The safety, immunogenicity and pharmacokinetics results further confirm that there is no clinically significant difference between the products,” adds the Swiss health group.
Sandoz expects to file for regulatory approval in the US and EU in the coming months. It is one of four high-value biosimilars it plans to launch over the next few years.
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