Biogen to commercialize Samsung Bioepis 2 new ophthalmology biosimilars Lucentis, Eylea in major markets worldwide

Under the terms of the proposed transaction, 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.

New Delhi: Biogen Inc. recently announced a new proposed transaction with Samsung Bioepis Co., Ltd. to secure the exclusive rights to commercialize two new ophthalmology biosimilars, SB11 referencing Lucentis and SB15 referencing Eylea, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia. In addition, Biogen will acquire exclusive commercialization rights for its anti-TNF portfolio, including BENEPALI (etanercept), FLIXABI (infliximab) and IMRALDI (adalimumab), in China. Biogen will also acquire an option to extend its existing commercial agreement with Samsung Bioepis for this anti-TNF portfolio in Europe.

“We are excited about the potential to bring biosimilars to a new therapeutic area as well as new regions around the world with the goal of sustainably advancing broad access to care for patients in need,” said Michel Vounatsos, Biogen’s Chief Executive Officer. “This transaction would expand the potential for our leading biosimilars business worldwide, while complementing Biogen’s presence in ophthalmology.”

Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s approved biological product, with the advantage that they offer cost savings and promote sustainable access to therapies. In Europe, over 180,000 patients have been treated with a Biogen anti-TNF biosimilar, and, based on its internal estimates, the company expects the uptake of BENEPALI, FLIXABI and IMRALDI to generate approximately 1.8 billion Euros in healthcare cost savings in 2019.

The proposed addition of the two ophthalmology biosimilars complements Biogen’s expanding efforts in this therapeutic area. Through the recent acquisition of Nightstar Therapeutics plc, a clinical-stage gene therapy company focused on treatments for inherited retinal disorders, Biogen acquired two mid- to late-stage clinical assets, as well as several preclinical programs, in ophthalmology.

Lucentis and Eylea are therapies widely used to treat ophthalmologic conditions such as neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) in patients with DME. In 2018 global sales for Lucentis and Eylea were almost $11 billion, with more than $5.8 billion spent in the U.S. alone.

Chirfi Guindo, Executive Vice President and Head of Global Product Strategy and Commercialization at Biogen, added “We believe savings enabled by biosimilars provide payers and health systems globally the budgetary headroom to fund innovation. According to a 2017 RAND Report, in the U.S. alone savings generated from biosimilar uptake could reach as high as $150 billion over a ten-year period5. We look forward to expanding our biosimilars portfolio in major markets worldwide.”

Under the terms of the proposed transaction, 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.

Biogen will also receive exclusive commercialization rights to BENEPALI, FLIXABI and IMRALDI in China in exchange for a royalty on sales in that market.

Upon closing, Biogen expects to record a charge to research and development expense of approximately $65 million related to the $100 million upfront payment.

The proposed transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 in the U.S. Biogen expects the deal to close in the fourth quarter of 2019.

Benepali (etanercept), a biosimilar referencing Enbrel, was approved by the European Commission (EC) in January 2016 for the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. Benepali is currently available in 25 countries in Europe and is the most prescribed etanercept in the five largest European countries (Germany, UK, France, Italy and Spain).

Flixabi (infliximab), a biosimilar referencing Remicade, was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. Flixabi can also be used in patients 6-17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. Flixabi is currently available in 17 countries in Europe.

Imraldi (adalimumab), a biosimilar referencing Humira, was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. Imraldi is currently available in 19 countries in Europe and is the leading adalimumab biosimilar in Germany and in Europe.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone.

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