Eye on Pharma: Samsung Bioepis to Partner With 3SBio on Biosimilars

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced that it will partner with Chinese biopharmaceutical company 3SBio to develop and commercialize multiple biosimilars in mainland China.

Under the agreement, which excludes Hong Kong, Macau, and Taiwan, Samsung Bioepis will hold responsibility for manufacturing and supplying its biosimilar products, and will collaborate with 3SBio on clinical development, regulatory registration, and commercialization across mainland China. 3SBio will provide an upfront payment and product supply income to Samsung Bioepis, as well as additional payments associated with clinical and regulatory milestones.

Among the products encompassed by the agreement is SB8, a proposed bevacizumab biosimilar referencing Avastin. The bevacizumab candidate is currently undergoing a phase 3 clinical trial; in NCT02754882, SB8 is being compared with EU-licensed reference bevacizumab, in combination with carboplatin and paclitaxel, in 763 patients with metastatic or recurrent non-squamous non—small cell lung cancer (NSCLC).

According to Samsung Bioepis and 3SBio, the companies will focus on the sales of SB8 in the indications of NSCLC and metastatic colon cancer. In China, colon cancer has an incidence rate of 26.6 cases per 100,000 people, and the incidence rate, which is higher in urban areas, is on the rise. NSCLC, with an incidence rate of 51.9 cases per 100,000 people, has the highest incidence rate among all malignancies in China.

"Samsung Bioepis possesses leading biologic development and manufacturing capabilities in the global market, combined with 3SBio's advantageous integrated platform in China, the 2 parties can provide patients in China with safe and affordable biological therapies,” Jing Lou, PhD, chairman and chief executive officer of 3SBio, said in a statement announcing the partnership. “3SBio looks forward to accelerating the clinical development of SB8 in China, and to broaden 3Bio's product portfolio in the oncology area.”

Christopher Hansung Ko, president and chief executive officer of Samsung Bioepis, added that his company looks forward to its expansion into China and to widening Chinese patients’ access to care.

Among Samsung Bioepis’ other biosimilar assets are widely approved biosimilars of etanercept (Brenzys), infliximab (Renflexis, Flixabi), adalimumab (Imraldi), and trastuzumab (Ontruzant). In addition to SB8, other biosimilars currently undergoing clinical trials are SB11, a proposed ranibizumab biosimilar referencing the eye drug Lucentis, and SB12, a proposed eculizumab biosimilar referencing the rare disease drug Soliris.