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.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six late-stage candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
i Humira® is a registered trademark of AbbVie Inc.