The agreement covers multiple biosimilar candidates from Samsung Bioepis, including third-wave biosimilar candidates SB11 and SB12, which reference LUCENTIS (ranibizumab) and SOLIRIS (eculizumab), respectively, as well as SB3, a biosimilar candidate referencing HERCEPTIN 3 (trastuzumab).
Under the agreement, C-Bridge will establish a new biopharmaceutical company, AffaMed Therapeutics, which will collaborate with Samsung Bioepis across a number of areas, including clinical development, regulatory registration and commercialization in China.
Samsung Bioepis will receive an upfront payment, as well as royalties on sales. Additional financial details were not disclosed.
“We want to play an important role in widening access to high-quality healthcare for patients throughout China. C-Bridge is the right partner for this mission as evidenced in its exceptional track record of successfully turning portfolio companies like AffaMed Therapeutics into leading biopharmaceutical companies in China and beyond,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis.
“At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.”
Established in February 2012, Samsung Bioepis currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI (etanercept), FLIXABI (infliximab) and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT (trastuzumab).
In the United States, the company has one biosimilar – RENFLEXIS (infliximab-abda) –.on the market, while another biosimilar – ONTRUZANT (trastuzumab-dttb) – has been approved by the U.S. Food and Drug Administration (FDA). A Biologics License Application (BLA) for SB5 (adalimumab) biosimilar candidate is currently under review at the FDA.
In total, over 100,000 patients across the world are currently under treatment with Samsung Bioepis’ biosimilars, with over 6 million doses administered.
Source: Company Press Release