medwireNews: The EMA has adopted a positive opinion on the use of a biosimilar formulation of pegfilgrastim for the prevention of neuotropenia, but has refused authorisation for the use of a generic cabazitaxel in men with prostate cancer.
The Committee for Medicine Products for Human Use recommended that Grasustek 6 mg solution (Juta Pharma GmbH, Flensburg, Germany) be granted marketing authorization for the prevention of neutropenia in adult patients with cancer who require cytotoxic chemotherapy. However, this positive opinion does not include use in patients with chronic myeloid leukemia or myelodysplastic syndromes.
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The Committee adopted a negative opinion for marketing authorization for the hybrid medicine Cabazitaxel Teva (Teva Europe BV, Amsterdam, the Netherlands), alongside prednisone or prednisolone, in patients with metastatic castration-resistant prostate cancer, who have previously been treated with docetaxel.
The generic formulation was put forward for consideration as a hybrid medicine, referencing the branded cabazitaxel and docetaxel formulations. But the Committee was unable to conclude that cabazitaxel offers equivalent efficacy and safety to docetaxel and refused the application.
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