Biogen will pay Samsung Bioepis KRW 748.6 billion ($673.4 million) to increase its minority stake in biosimilars developer Samsung Bioepis, a joint venture of Biogen and Samsung BioLogics.

Biogen said it has exercised its option to purchase additional shares of the joint venture, which will raise its minority stake from approximately 5.4% to approximately 49.9%. Biogen will buy 9,226,068 shares valued at KRW 2.26 trillion ($2 billion), in a deal expected to occur on September 28, Samsung Bioepis stated in a regulatory filing.

“We are very pleased with the progress made to date at Samsung Bioepis and believe exercising this option is an opportunity to create meaningful value for our shareholders,” Biogen CEO Michel Vounatsos said in a statement. “This option allows us to increase our ownership share in a leading biosimilar company at what we believe are attractive terms. We look forward to building an important relationship with Samsung BioLogics.”

The share purchase is subject to regulatory closing conditions and is expected to close in the second half of 2018.

The share exercise will also be scrutinized by South Korea’s Financial Services Commission, which Samsung BioLogics has challenged after the regulator alleged that the company violated accounting regulations when it switched its method of valuation for Samsung Bioepis—a switch that caused the valuation to jump 18-fold, to approximately $4.5 billion in 2015. Samsung BioLogics has denied wrongdoing and said a different method was needed in the event Biogen exercised its stock purchase option.

Samsung BioLogics in 2012 joined Biogen to create Samsung Bioepis, which is developing a pipeline of biosimilar candidates that includes six late-stage candidates for indications that include immunology, oncology, and diabetes.

One Samsung Bioepis candidate, SB4, is a biosimilar to Amgen/Pfizer-marketed Enbrel® (etanercept) that has gained approvals by the European Commission (EC) as well as regulatory bodies in South Korea, Australia, Canada, and Brazil.

The EC and FDA have given full approval to another candidate, SB2, a biosimilar to the Johnson & Johnson/Merck & Co.-marketed Remicade® (infliximab) that has also been authorized by regulators in South Korea, Australia, and Canada. The FDA has granted tentative approval to another EC-approved Samsung Bioepis candidate, SB9, a biosimilar to Sanofi’s Lantus® (insulin glargine), and has accepted for review a filing for SB3, a biosimilar to Genentech (Roche)’s Herceptin® (trastuzumab).

Also in Samsung Bioepis’ pipeline are: SB5, a biosimilar to AbbVie’s Humira® (adalimumab) with approvals from the EC, South Korea, Australia, and Canada; and SB8, a biosimilar to Genentech (Roche)’s Avastin® (bevacizumab) that is undergoing Phase III clinical trials.

According to ClinicalTrials.gov, Samsung Bioepis is recruiting patients for a study comparing another pipeline candidate SB11, a biosimilar to Genentech (Roche)’s Lucentis® (ranibizumab), to the reference product (NCT03150589).

Biogen and Samsung Bioepis are also recruiting patients for another clinical trial, an observational study designed to assess the effectiveness of the Biogen biosimilar Benepali in participants with rheumatoid arthritis and axial spondyloarthritis (axSpA), including participants with ankylosing spondylitis and nonradiographic axSpA, following their transition from treatment with Enbrel (NCT03100734).








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