April 25, 2024

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[THE INVESTOR] Samsung Bioepis said Sept. 16 it has received backing from the European Medicines Agency for its copy version of Roche’s blockbuster breast cancer drug Herceptin.

The EU drug regulator’s recommendation for approving Samsung Bioepis’ Ontruzant will bolster its bid to become the first company to commercialize cancer biosimilar in the region. 

If the European Commission grants marketing approval, which normally takes two to three months following EMA backing, the Korean biotech firm will instantly challenge Roche, which earns nearly 8 trillion (US$7.06 billion) won from Herceptin sales.

“We are proud to see Ontruzant become the first trastuzumab biosimilar recommended for approval in Europe, where breast cancer remains the most common form of cancer affecting women. If approved, we hope Ontruzant will play an important role in expanding patient access to trastuzumab across the region,” said Ko Han-sung, CEO of Samsung Bioepis in a press release.

Samsung Bioepis will be able to make Ontruzant available to European pharmacies immediately after clearing the final regulatory hurdle as the original drug’s patent had expired three years ago. It loses US patent protection in 2019.

If successful, Ontruzant will become Samsung Bioepis’ fourth biosimilar product to win European approval following its versions of top-selling inflammatory therapies Remicade, Enbrel and Humira - Flixabi, Benepali and Imraldi.

The joint venture between Samsung BioLogics and Biogen is putting itself ahead of a pack of rivals developing their Hercepin copycats such as crosstown rival Celltrion and India’s Biocon, which withdrew its filing in August.

By Park Han-na (hnpark@heraldcorp.com)