The European Commission (EC) has approved Celltrion Inc's Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification, the company disclosed on Wednesday.

The EC's decision follows a positive opinion given by the Committee for Medicinal Products for Human Use (CHMP) on 14 December 2017.

Herzuma is an anticancer monoclonal antibody (mAb) biosimilar drug that references Herceptin. The similarity was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials.

The EC's approval means Herzuma will now be available in the 28 member states of the European Union, as well as Norway, Lichtenstein and Iceland. The company launched the drug in Korea last year.

Herzuma is the company's third biosimilar to be approved by the EC.