BASEL, Switzerland — Sandoz recently announced that the generic manufacturer continues to advance its biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase.
For example, Sandoz completed the patient enrollment for its Phase III trial with biosimilar etanercept (Amgen's Enbrel). The global clinical trial seeks to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis.
Sandoz also completed a Phase III trial for the U.S. registration of biosimilar filgrastim (Amgen's Neupogen) and two global Phase III trials for global registration of biosimilar pegfilgrastim (Amgen's Neulasta). The trials aimed to confirm biosimilarity of the Sandoz biosimilars versus Neupogen and Neulasta in breast cancer patients eligible for myelosuppresive chemotherapy treatment. Sandoz is currently preparing to file Filgrastim in the United States, and pegfilgrastim in the United States and Europe.
Sandoz also continues to make strong progress on its other biosimilar clinical development programs, which includes biosimilar versions of rituximab (Roche's Rituxan/MabThera) and adalimumab (AbbVie's Humira).