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Samsung Bioepis Herceptin biosimilar accepted for review in EU

Dan Stanton

By Dan Stanton+

04-Oct-2016
Last updated on 04-Oct-2016 at 10:22 GMT2016-10-04T10:22:04Z

Samsung Bioepis Herceptin biosimilar accepted for review in EU

The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.

Samsung Bioepis - a collaboration between Samsung Biologics and Biogen – announced its version of Herceptin, known as SB3, had been accepted for review late last night.

The candidate is the fifth biosimilar submitted to the European Medicines Agency (EMA) by the company following versions of AbbVie’s Humira (adalimumab), Sanofi’s Lantus (insulin glargine), Amgen’s Enbrel (etanercept) and Janssen’s Remicade (infliximab).

The latter two have received approval in Europe and are being marketed by Samsung Bioepis’s commercial partner Biogen under the brand names Benepali and Flixabi, respectively.

However, if approved SB3 will be marketed by Merck & Co, known as MSD outside of North America, through an agreement inked in February 2013 between the two firms.

The monoclonal antibody has long been a bestseller for Roche, and last year clocked in over 6.5bn CHF ($6.7bn) of sales for the Swiss pharma firm.

This is the second publically-announced submission of a biosimilar version of Herceptin submitted in Europe after Mylan and Biocon submitted their version in August this year . The primary patents expired in Europe in July 2014 , following a court ruling in favour of biosimilar developer Hospira, now part of Pfizer.

However, the biologic already faces competition in other markets, including India where Mylan/Biocon’s Canmab was approved in December 2013 , and fellow Korean drugmaker Celltrion saw success in its home market with its product Herzuma being approved in 2014 . Meanwhile, Biocad had its biosimilar HERtiCAD approved in Russia in January this year

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