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27-03-2018 | EMA | News


EMA updates for biosimilar trastuzumab, generic pemetrexed


medwireNews: The EMA has adopted positive opinions to grant marketing authorizations for a biosimilar to the human epidermal growth factor receptor 2 (HER2) inhibitor trastuzumab and a generic formulation of the folate antimetabolite pemetrexed.

ABP 980 may be used for the same indications as the originator trastuzumab, namely for the treatment of patients with confirmed overexpression of HER2 or HER2 gene amplification in early or metastatic breast cancer, or metastatic cancer of the stomach or gastroesophageal junction.

This announcement follows the US FDA’s approval of the biosimilar trastuzumab-dkst for the treatment of breast and gastric cancer with HER2 overexpression.


The EMA’s Committee for Medicinal Products for Human Use has also given a positive opinion for marketing authorization of pemetrexed Krka, a generic formulation of the antifolate agent pemetrexed.

Pemetrexed Krka may be used in patients with locally advanced or metastatic non-small-cell lung cancer in patients with tumours that are not predominantly formed of squamous cell histology. Specifically, the agent may be given in combination with cisplatin as a first-line therapy, as a maintenance monotherapy for patients whose disease has not immediately progressed on platinum-based chemotherapy, and as a second-line monotherapy.

In addition, the generic formulation may also now be used alongside cisplatin for treatment-naïve patients with unresectable malignant pleural mesothelioma.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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