Biogen Sells Stake in Biosimilar Venture Samsung Bioepis

After a nearly a decade of collaboration, Biogen is selling its stake in the biosimilar joint venture Samsung Bioepis to partner Samsung Biologics. The 2 companies reached an agreement that Samsung Biologics will buy out the stake for up to $2.3 billion.

The joint venture was launched in 2012 when Biogen invested a 15% stake in Samsung Bioepis and Biogen had the right to purchase up to 50% less 1 share, which it did in June 2018.

“We are thankful to Samsung Biologics for a productive collaboration since 2012,” Michel Vounatsos, CEO at Biogen, said in a statement. “We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen.”

There is a total of 5 FDA-approved biosimilars from Samsung Bioepis:

• Eticovo (etanercept), approved to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis (PsA), plaque psoriasis, and ankylosing spondylitis (AS). There is a total of 2 etanercept biosimilars approved in the United States, although neither have come to market yet.
• Renflexis (infliximab), a tumor necrosis factor blocker approved to treat Crohn disease, ulcerative colitis (UC), RA, AS, PsA, and plaque psoriasis. A total of 4 infliximab biosimilars are approved in the United States and 3 have been launched. The fourth, Ixifi from Pfizer, will not be marketed in the United States to avoid competition with Inflectra, which is also from Pfizer.
• Hadlima (adalimumab), approved for RA, juvenile idiopathic arthritis, PsA, AS, Crohn disease, UC, and plaque psoriasis. There are 7 adalimumab biosimilars approved in the United States. While none have come to market yet, they are all expected to launch in 2023 as a result of settlement agreements with the reference producer, AbbVie.
• Ontruzant (trastuzumab), approved to treat HER2-positive breast cancer and HER2 overexpressing gastric cancer. There are 5 trastuzumab biosimilars approved and all of them have launched. Ontruzant was approved January 2019 and launched April 2020.
• Byooviz (ranibizumab), an anti-vascular endothelial growth factor therapy approved to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

In addition, a bevacizumab biosimilar is approved in Canada, the European Union, and the Republic of Korea. The company has eculizumab, aflibercept, denosumab, and ustekinumab biosimilars all in phase 3 clinical trials.

The company also has a novel biologic in the pipeline. SB26 is an ulinastatin-Fc fusion protein that is intended to treat severe acute pancreatitis. It is currently in a phase 1 trial and being studied in healthy volunteers.

“The full buyout of Biogen’s stake is expected to accelerate Samsung Bioepis’ biosimilar development capabilities and future performance in novel drug development, with improved autonomy and agility in business operations,” according to a press release for Samsung Biologics.

As part of the agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over 2 payments: $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the transaction close. In addition, Biogen is eligible to receive up to $50 million upon achievement of certain commercial milestones.