The European Commission has approved Celltrion Healthcare’s Herzuma, a biosimilar of Roche/Genentech’s blockbuster Herceptin.
The drug has been cleared for use across all indications of its reference product, that is for the treatment of people with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification.
The decision comes after Herzuma (trastuzumab) was shown to be highly similar to Herceptin in terms of efficacy, safety, immunogenicity, pharmacodynamics and pharmacokinetics, the firm noted.
Herceptin, a biologic drug developed by Genentech and marketed by Roche, pulled in worldwide sales of $6.8billion in 2016, of which $2.1 billion stemmed from Europe.
“There is an increasing number of European national healthcare systems that are challenged by the high cost burden of oncology treatments. Subsequently, the approval of Herzuma will be greatly welcomed, as it provides a high-quality treatment alternative for patients, while offering significant potential savings and headroom for other oncology treatments,” noted Richard Trollope, Head of Biosimilars at Mundipharma, speaking at Celltrion Healthcare’s annual Partner Summit in Venice earlier this month.
Herzuma, which is also referred to as CT-P6 and marks the third Celltrion Healthcare product approved in the EU, is also under review in the US.