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Biogen unveils plan to commercialise Eylea and Lucentis generics

Multinational biotech company Biogen has proposed a deal worth up to US$310 million (AU$453 m) to supply biosimilar treatments of Lucentis and Eylea to major global markets, including Australia.

The US-based drug developer has outlined plans to purchase the rights and commercialise generic versions of the therapies from Samsung Bioepis, a joint venture Biogen established with South Korean firm Samsung BioLogics in 2012.

Regeneron/Bayer’s Eylea and Roche/Novartis’ Lucentis are the two leading therapies for neovascular age-related macular degeneration (nAMD), as well as other associated diseases such as macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

In 2018, combined global sales for the drugs reached almost US$11 billion (AU$15.9 b), with the US accounting for more than US$5.8 billion (AU$8.4 b) alone. However, Eylea patents in Europe and Australia are due to lapse in 2025, and even sooner in US and some Asian markets, while Lucentis faces expiration in the US next year and Europe in 2022

Biogen intends to commercialise its own cheaper versions of the treatments in major global markets, including the US, Canada, Europe, Japan and Australia where Eylea and Lucentis are listed on the Pharmaceutical Benefits Scheme.

“We believe savings enabled by biosimilars provide payers and health systems globally the budgetary headroom to fund innovation,” Mr Chirfi Guindo, Biogen executive vice president and head of global product strategy and commercialisation, said.

“In the US alone savings generated from biosimilar uptake could reach as high as US$150 billion (AU$217 b) over a 10-year period. We look forward to expanding our biosimilars portfolio in major markets worldwide.”

The proposed deal would see Biogen pay US$100 million (AU$145 m) upfront to Samsung Bioepis. Biogen may also pay Samsung Bioepis up to US$210 million (AU$304 m) in additional development, regulatory and sales-based milestones. Samsung Bioepis will be responsible for development and will supply products to Biogen at a pre-specified gross margin.

The addition of the two ophthalmology biosimilars forms part of Biogen’s wider efforts to increase its presence in eyecare and futureproof its business. In June, the company acquired Nightstar Therapeutics for US$800 million (AU$1.1 b), a clinical-stage gene therapy company focused on treatments for inherited retinal disorders.

The company expects the deal to close in the fourth quarter of 2019.