Samsung Bioepis has entered into a new commercialization agreement with Biogen for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the United States, Canada, Europe, Japan, and Australia. SB11, a biosimilar candidate referencing Lucentis (ranibizumab), is undergoing phase 3 clinical trial, while SB15, a biosimilar candidate referencing Eylea (aflibercept), is in preclinical development.
In addition, the agreement provides Biogen an option to extend the commercialization term for Samsung Bioepis’ three anti-TNF biosimilars–Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab)–in Europe for additional 5 years, extending the original 10-year agreement. Benepali is the most prescribed etanercept in France, Germany, Italy, Spain, and the United Kingdom (UK). Imraldi is the leading adalimumab biosimilar in Europe.
Under the agreement, Samsung Bioepis will receive upfront payments of $100 million, up to $270 million in milestone/option payments, as well as sharing of sales revenue. Samsung Bioepis will be responsible for development, regulatory registration, and manufacture of the products, while Biogen will be responsible for commercialization.
“In Europe, we have been very pleased with Biogen’s commercialization efforts with our anti-TNF medicines, fulfilling the mission of expanding access to high-quality medicines to patients across Europe. By building on this collaboration, we are excited to potentially expand the opportunity for patients living with ophthalmological conditions, who don’t have access to life-changing medicines,” Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis, said in a company news release. “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.”
Samsung Bioepis’ products are now available across Europe, North America, Asia, Oceania, and Latin America.