INCHEON, Korea – April 5, 2018 - Samsung Bioepis Co., Ltd. today announced that it has signed a licensing agreement with AbbVie Inc., settling all pending patent litigation between the two companies and clearing the way for the worldwide commercialization of Samsung Bioepis' SB5, a biosimilar referencing Humira®i (adalimumab). Under the terms of the agreement, Samsung Bioepis' SB5 may be launched in Europe from October 16, 2018 onwards and, if approved, in the United States (US) from June 30, 2023 onwards.
SB5 has been granted marketing authorization by the European Commission (EC) as IMRALDI®, and will be commercialized in Europe by Biogen. In the US, SB5 has not yet received regulatory approval.
"We welcome this agreement which clears the way for SB5 in approved markets across the world. The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region," said Jaywoo Kim, Senior Vice President and Head of the Commercial Division at Samsung Bioepis. "Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across the world may benefit from biosimilars.