Novartis’ subsidiary Sandoz has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the EirGenix-developed proposed trastuzumab biosimilar drug (150 mg).
Trastuzumab is a monoclonal antibody intended to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast and metastatic gastric cancers.
The company aims to secure EMA approval for the same indications. The submission is supported by preclinical, clinical, and analytical data of the proposed biosimilar trastuzumab for intravenous use.
Sandoz Biopharmaceuticals Development global head Florian Bieber said: “In 2020, breast cancer accounted for 28.7% of all new cancer cases diagnosed, making it the most frequently occurring cancer and first cause of cancer death among women in Europe.
“Biosimilars have enormous potential to improve cancer care. Today’s submission is an encouraging step forward in our mission to expand access to advanced biologics treatments to address the evolving needs of patients, healthcare professionals and healthcare systems.”
Recently, the company has submitted a biologics licence application to the US Food and Drug Administration (FDA) for the biosimilar drug of the same dose.
In April 2019, Sandoz and EirGenix have entered into a licence agreement for the trastuzumab biosimilar.
Under the deal, EirGenix will develop and manufacture the biosimilar drug while Sandoz will have rights to sell the drug upon receipt of approval in all markets excluding Taiwan and China.
In February this year, Sandoz signed an agreement to acquire GlaxoSmithKline’s (GSK) cephalosporin antibiotics business.
The deal includes global rights of Zinnat, Zinacef and Fortum brands.