Biogen to Sell Its Stake in the Biosimilar Venture Samsung Bioepis

In 2012, Biogen invested a 15% stake in Samsung Bioepis and then increased ownership up to 50% less 1 share in June 2018. However, it’s now extracting itself from the biosimlar joint venture with Samsung Biologics.

Biogen is selling its stake for up to $2.3 billion.

“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.”

Under the agreement, Biogen will receive $1 billion in cash at closing, $812.5 million at the first anniversary of the transaction close, and $437.5 million at the second anniversary of the transaction close. Biogen is also eligible to receive up to $50 million upon achievement of certain commercial milestones.

“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 from Samsung Biologics.

Samsung Bioepis’ Approved Drugs

In April 2019, FDA approved Eticovo, an etancercept biosimilar. At the time, the biosimilar had already been approved in a variety of other markets under the names Benepali and Brenzys.

The FDA approval was for all indications of the reference drug, Enbrel: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis (PsA), plaque psoriasis, and ankylosing spondylitis (AS).

Eticovo was the second etanercept biosimilar approved after Sandoz’s Erelzi; however, neither have launched in the United States yet.

Renflexis, an infliximab biosimilar to Remicade, was approved in April 2017. The tumor necrosis factor blocker was approved for multiple indications: adult and pediatric Crohn’s disease, ulcerative colitis (UC), RA, AS, PsA, and plaque psoriasis.

It was the second infliximab biosimilar approved after Inflectra from Celltrion/Pfizer. Since then, 2 others have been approved: Avsola and Ixifi. However, Ixifi will not be marketed in the United States since it is also from Pfizer and the company decided to avoid competing with Inflectra.

An adalimumab biosimilar (Hadlima) has been approved since July 2019, although it will not launch until June 2023 as a result of a settlement with AbbVie, the maker of the originator product, Humira. Hadlima is approved for RA, juvenile idiopathic arthritis, PsA, AS, Crohn disease, UC, and plaque psoriasis.

There are a total of 7 adalimumab biosimilars approved in the United States and Amjevita, the first approved in September 2016, will be the first to market with an anticipated launch of January 2023. Cytelzo was approved August 2017 and has an anticipated launch of July 1, 2023, but it has the added advantage of already being approved as an interchangeable biosimilar.

A trastuzumab biosimilar, Ontruzant, was approved in January 2019 to treat HER2-positive breast cancer and HER2 overexpressing gastric cancer, and it launched in the United States in April 2020. Another 4 trastuzumab biosimilars (reference, Herceptin) are approved and have launched.

Finally, the company has a ranibizumab biosimilar (Byooviz), which was approved September 2021. This is the first ranibizumab biosimilar of reference Lucentis, and it is the first ophthalmology biosimilar to gain approval. It is approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz will not launch until June 2022 due to a licensing agreement between Samsung Bioepis and Biogen and the originator company, Genentech.

Outside of the United States, Samsung Bioepis has a bevacizumab biosimilar, which is sold as Aybintio in Canada and the European Union and as Onbevzi in the European Union and the Republic of Korea.

In the Pipeline

In addition to the approved biosimilars, Samsung Bioepis has 5 additional products in the pipeline.

SB12 is an eculizumab biosimilar based on Soliris, an immunosuppressive drug that treats paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. SB12 is currently in a phase 3, randomized, double-blind, multicenter, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris (NCT04058158).

The company also has a second ophthalmology candidate with SB15, an aflibercept biosimilar based on the reference product Eylea. This is also in phase 3 with a randomized, double-masked, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of SB15 vs Eylea in patients with neovascular AMD (NCT04450329).

SB16 is a denosumab biosimilar to reference product Prolia in a phase 3, randomized, double-blind, multicenter study evaluating the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of the biosimilar compared with Prolia in postmenopausal women with osteoporosis (NCT04664959).

Finally, SB17 is a ustekinumab biosimilar candidate to reference product Stelara. It is in a phase 3, randomized, double-blind, multicenter study to evaluate the safety, efficacy, tolerability, pharmacokinetics, and immunogenicity of the biosimilar compared with Stelara in patients with moderate to severe plaque psoriasis.

In addition to the biosimilars in the pipeline, Samsung Bioepis also has SB26, a novel biologic. It is an ulinastatin-Fc fusion protein that is intended to treat severe acute pancreatitis, and it is in a phase 1 trial.