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Biogen takes on Lucentis, Eylea biosimilars from Samsung joint venture

Will pay $100m upfont and pledges $210m in milestone payments

Biogen

Biogen has licensed two more biosimilar drugs – both versions of blockbuster therapies for eye disease age-related macular degeneration (AMD) – from its joint venture Samsung Bioepis.

Under the deal, Biogen is taking exclusive rights to Samsung Bioepis’ SB11, a biosimilar of Novartis/Roche’s Lucentis (ranibizumab), as well as SB15 which is a version of Regeneron/Bayer’s Eylea (aflibercept), which together account for the lion’s share of the wet AMD market by value.

Biogen is paying $100m upfront for the rights, and pledging another $210m in milestone payments tied to development, regulatory and sales targets for the two products.

Lucentis was the first VEGF inhibitor to reach the market for wet AMD and grew quickly into a blockbuster product with sales of around $3.7bn last year.

It has since been overtaken by rival VEGF drug Eylea, with Regeneron reporting $4bn in US sales last year and Bayer adding another $2.1bn from other markets.

Those sales figures have no doubt enticed Biogen to swoop on SB11 and SB15 as the two market leaders approach the end of their patent life. Lucentis is due to lose protection in the US next year and in 2022 in Europe, while Eylea’s patents will lapse in 2020 and 2021 in the two markets, respectively.

Novartis recently claimed a US approval for a follow-up VEGF inhibitor Beovu (brolucizumab), which requires fewer injections into the eye, in an attempt to protect its AMD franchise ahead of biosimilar competition.

Meanwhile, off-label use of Roche’s VEGF inhibitor Avastin (bevacizumab) continues to be a low-cost alternative to the approved treatments for wet AMD, while Allergan has a new longer-acting VEGF – abicipar pegol – filed for approval in the US and Europe.

SB11 and SB15 will face competition from rival biosimilars of course. Alteogen and Momenta/Mylan have versions of Eylea in development, while Coherus and Xbrane Pharma are among companies which are working on Lucentis biosimilars.

Meanwhile, as a rider to the licensing deal, Biogen has also taken on exclusive commercial rights to three other Samsung Bioepis TNF inhibitor biosimilars in China – Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).

It has also agreed an option to extend its rights to those drugs in Europe in return for a $60m license fee.

Biogen said the new licensing deal continues its expansion into ophthalmology through the recent $800m acquisition of gene therapy specialist Nightstar Therapeutics.

Article by
Phil Taylor

7th November 2019

From: Sales

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