Biogen has proposed a new $310-million transaction with Samsung Bioepis, a biosimilar biopharmaceutical joint venture between Samsung BioLogics and Biogen, for the exclusive rights to commercialize two new ophthalmology biosimilars, SB11 referencing Roche’s Lucentis (ranibizumab) and SB15 referencing Bayer’s and Regeneron Pharmaceuticals’ Eylea (aflibercept). Biogen will also have rights to three rheumatoid arthritis biosimilars in China.

Lucentis and Eylea are therapies used to treat ophthalmologic conditions such as neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME) and diabetic retinopathy in patients with DME. In 2018, sales for Lucentis and Eylea were more than $5.8 billion in the US, based on company information and information from Evaluate Pharma and as reported by Biogen. 

Under the agreement, Biogen will make a $100-million upfront payment to Samsung Bioepis. Additionally, Biogen may pay Samsung Bioepis up to $210 million in additional development, regulatory and sales-based milestones. Samsung Bioepis will be responsible for development and will supply both products to Biogen at a pre-specified gross margin. Biogen will also obtain an option to extend the term of its current European commercial agreement for its three anti-TNF biosimilars by an additional five years, subject to payment of an option exercise fee of $60 million.  Upon closing, Biogen expects to record a charge to research and development expense of approximately $65 million related to the $100-million upfront payment.

Under the agreement, Biogen will have commercialization rights in major markets worldwide, including the US, Canada, Europe, Japan and Australia. In addition, Biogen will acquire exclusive commercialization rights for its anti-TNF portfolio, including the rheumatoid arthritis and biosimilar drugs Benepali (etanercept), a biosimilar of Amgen’s/Pfizer’s Enbrel, Flixabi (infliximab), a biosimilar of Johnson & Johnson’s Remicade, and Imraldi (adalimumab), a biosimilar of AbbVie’s Humira, in China. Biogen will receive the commercialization rights in exchange for a royalty on sales in that market.

Through the recent acquisition of Nightstar Therapeutics, a clinical-stage gene therapy company, Biogen acquired two mid- to late-stage clinical assets, as well as several preclinical programs, in ophthalmology.

Biogen expects the deal to close in the fourth quarter of 2019.

Source: Biogen