Samsung Bioepis files Herceptin biosimilar in EU

Samsung Bioepis has become the latest firm to mount a challenge to Roche’s breast cancer blockbuster Herceptin (trastuzumab) in Europe, after announcing  that the regulator accepted a filing for a near-copy.

The South Korean-based joint venture between Samsung and Biogen said the European Medicines Agency (EMA) had accepted its filing for SB3, a biosimilar of Herceptin, which went off patent in the EU in 2014.

Mylan and Biocon were the first companies to announce a Herceptin biosimilar filing in Europe back in August, meaning the breast cancer drug could face competition late next year.

However Samsung Bioepis said it had also filed its biosimilar around that time.

SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following near copies of Amgen/Pfizer’s Enbrel (etanercept), Johnson & Johnson’s Remicade (infliximab), Sanofi’s Lantus (insulin glargine) and AbbVie’s Humira (adalimumab). The Enbrel and Remicade biosimilars have since been approved in Europe.

SB3 is also the company’s first oncology biosimilar candidate submitted for regulatory review in Europe. If approved, the marketing and distribution of SB3 in Europe will be handled by MSD.

With sales of $6.6 billion globally last year, Herceptin is one of several big-selling biologic drugs that have gone off-patent, or are due to lose protection over the coming years.

IMS Health estimated that biosimilars of these drugs could save the US and the largest health systems in the EU up to $110 billion.

The drugs include AbbVie’s Humira (adalimumab), the world’s biggest-selling drug, with sales of $14 billion last year.

However the originator companies are likely to put up a fight, and have set up a series of extra patent defences around their medicines, potentially delaying launches of rivals.