Bioepis approved for first clinical trials in China

Samsung Bioepis is set to begin its first clinical trials ever in China, as it starts testing a biosimilar for treating breast cancer.

The company, which is a joint venture between Samsung BioLogics and Cambridge, Massachusetts-based Biogen, said Tuesday that China’s National Medical Products Administration approved its application to start Phase 3 clinical trials of SB3, a biosimilar that references Roche’s Herceptin.

Samsung Bioepis plans to start the trials in the first quarter next year with 208 Chinese breast cancer patients. It aims to prove that SB3 is as safe and as effective as Herceptin. The company’s products have been performing well in Europe, and it has been eyeing expansion to other key markets.

Biosimilars are biological products that are approved based on evidence that they are highly similar to already approved products. The drugs have no meaningful clinical differences in terms of safety or effectiveness from the reference product.

SB3 was already approved as Samfenet in Korea and Ontruzant in Europe and the United States. Herceptin is a leader in the breast cancer treatment, with annual sales around $7 billion.

Samsung Bioepis said it will be working with Affamed Therapeutics, its joint venture with C-Bridge Capital, a Chinese health care venture fund management company specialized in the health care sector.

C-Bridge Capital and Samsung Bioepis signed an agreement in February to collaborate on trials, regulatory applications and the commercialization of Samsung Bioepis products in China. The two companies plan to work on commercializing three biosimilar products in addition to SB3.

Samsung Bioepis, which was founded in 2012, is expected to turn a profit for the first time this year due to strong sales of biosimilars, like Benepali and Imraldi in Europe.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]