Biogen signs marketing deal for two ophthalmology biosimilars

Biogen has gained rights to market two potential ophthalmology biosimilars in major markets including the US, Europe and Japan, under a new agreement signed with Samsung Bioepis.

Samsung Bioepis is a joint venture between Biogen and Samsung and already has several biosimilars on the market across the world, including a near-copy of Johnson & Johnson/MSD’s inflammatory diseases drug Remicade (infliximab).

Biogen already markets these in Europe, and the new agreement builds on this by giving it marketing rights to biosimilars of Novartis’ Lucentis (ranibizumab) and Bayer/Regeneron’s Eylea (aflibercept) in the US, Canada, Europe, Japan and Australia.

SB11, a biosimilar reference Lucentis is in a phase 3 trial, while the Eylea biosimilar, SB15, is in pre-clinical development.

Eylea is a blockbuster that generated revenues of more than $6.7 billion in 2018, while Lucentis’ sales were more than $2 billion, with both drugs competing in lucrative ophthalmology niches include wet age-related macular degeneration.

US patents on both drugs are set to expire next year, with Eylea’s European patent set to go in 2021, followed by Lucentis the following year. Several manufacturers are developing cheaper competitors to grab market share from the originator companies.

Biogen also gets an option to extend its marketing agreement for Samsung Bioepis’ three anti-TNF class biosimilars in Europe for another five years, extending an original ten-year agreement.

This covers biosimilars referencing Pfizer’s Enbriel (etanercept),  Remicade, and AbbVie’s Humira (adalimumab), branded as Benepali, Flixabi, and Imraldi, respectively.

Citing IQVIA data, Samsung Bioepis said that Benepali is the most prescribed etanercept in France, Germany, Italy, Spain and the UK, and Imraldi is the leading adalimumab biosimilar in Europe.

The new agreement also gives Biogen an option to receive marketing rights to the three anti-TNF biosimilars in China.

Samsung Bioepis will receive upfront payments of $100 million, up to $270 million in milestone or option payments, as well as sharing of sales revenue.

Samsung Bioepis will be responsible for development, regulatory registration, and manufacture of the products, while Biogen will be responsible for marketing.

Christopher Hansung Ko, president and CEO of Samsung Bioepis, said: “In Europe, we have been very pleased with Biogen’s commercialisation efforts with our anti-TNF medicines, fulfilling the mission of expanding access to high-quality medicines to patients across Europe.”

Biosimilars are near-copies of complex biologic drugs that are grown in cells, and have been shown to as safe and effective as the original through a series of analyses and clinical trials submitted to regulators.

 

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