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First Herceptin biosimilar cleared in Europe

Ontruzant is approved for all the same indications as Roche’s blockbuster

Herceptin

Samsung Bioepis has claimed the distinction of getting the first biosimilar of Roche’s $6.8bn breast cancer blockbuster Herceptin in the EU.

The South Korea-based joint venture between Samsung and Biogen says the new biosimilar, called Ontruzant, has been approved for the full range of registered indications for Herceptin (trastuzumab), including early breast cancer, metastatic breast cancer and metastatic gastric cancer.

Samsung Bioepis’ development partner for the biosimilar, Merck & Co (known as MSD in Europe), will commercialise the drug in Europe under the terms of a collaboration between the two companies agreed in 2013. The drug has so far not revealed its launch or pricing plans for the new product.

Ontruzant as a 150mg powder for concentrate for solution for infusion was recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in September, and approval means it can now threaten the CHF 2.1bn in European sales achieved by Herceptin last year.

Herceptin is also facing the threat of competition in the US, where it made $2.5bn in sales last year, with the FDA’s Oncologic Drugs Advisory Committee (ODAC) voting in favour of approval for Biocon and Mylan’s version of the drug in September. The US regulator has however delayed making a decision on the application by three months, setting back its review date to the end of this year.

Biocon and Mylan withdrew the filing for their biosimilar in the EU, after questions were raised about manufacturing quality compliance issues, but said recently these have been resolved, putting a re-submission on the cards.

Meanwhile, Roche has turned to the courts to try to defend its franchise in the US, filing a lawsuit against Pfizer - which has a Herceptin biosimilar called PF-05280014 filed with the FDA but not yet approved - for patent infringement. Roche is claiming patent protection for Herceptin in the US out to 2019, but its EU patents expired in 2014.

“Breast cancer remains the most common form of cancer affecting women. We hope Ontruzant will play an important role expanding patient access to trastuzumab across the region,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis, in a statement.

Ontruzant is the fourth biosimilar developed by the Korean company to receive marketing authorisation in the EU. It has also been granted approval for Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab).

Article by
Phil Taylor

22nd November 2017

From: Regulatory

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