Samsung Bioepis Inks Commercialization Agreement for Its Next Wave of Biosimilars

Samsung Bioepis announced Wednesday that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development.

The agreement relates to SB11, a proposed ranibizumab biosimilar referencing Lucentis, and SB15, a proposed aflibercept biosimilar referencing Eylea, in the US, Canada, Europe, Japan, and Australia. SB11 is currently in a phase 3 clinical trial, while SB15 is in preclinical development.

The agreement also gives Biogen the option to extend by 5 years its existing 10-year commercialization agreement for 3 anti—tumor necrosis factor (anti-TNF) biosimilars in Europe. The anti-TNF agents are an etanercept biosimilar (Benepali, which is also approved in the US context as Eticovo, though it remains unlaunched), an infliximab biosimilar (Flixabi, approved in the US market as Renflexis, where it commercialized by Merck), and an adalimumab biosimilar (Imraldi, which is approved, but unlaunched, in the United States as Hadlima).

The deal also allows Biogen to receive commercialize the 3 anti-TNF agents in China in exchange for royalties on sales.

“In Europe, we have been very pleased with Biogen’s commercialization efforts with our anti-TNF medicines, fulfilling the mission of expanding access to high-quality medicines to patients across Europe. By building on this collaboration, we are excited to potentially expand the opportunity for patients living with ophthalmological conditions, who don’t have access to life-changing medicines,” said Christopher Hansung Ko, president and chief executive officer of Samsung Bioepis, in a statement announcing the deal.

Biogen has so far seen strong results from its biosimilar commercialization efforts; at a recent meeting, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, told attendees that 170,000 patients with inflammatory diseases have now been treated with one of the partnership’s biosimilars, generating $1.8 billion in savings across Europe this year.

In the United Kingdom alone, the savings from biosimilars have allowed 44% more patients to be treated with anti-TNF agents, he added.