Ten years after the formation of biosimilar-focused joint venture Samsung Bioepis, Biogen is finally launching its first U.S. biosimilar.
Together with Samsung Bioepis, Biogen is commencing marketing activities of Byooviz, a copycat referencing Roche’s blockbuster eye drug Lucentis. Approved by the FDA in September, the drug will soon become the first ophthalmology biosimilar in the U.S.
For now, Byooviz’s FDA approval covers Lucentis’ indications of wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. The biosimilar currently isn’t allowed for diabetic macular edema or diabetic retinopathy because the dosing formulation is different, Kyung-ah Kim, Ph.D., Samsung Bioepis’ executive vice president and development division leader, explained in an interview with Fierce Pharma.
Byooviz will be commercially available July 1. Because the drug is the first biosimilar for eye diseases, Biogen will first educate ophthalmologists about the science of biosimilars as well as the data, a Biogen spokesperson told Fierce Pharma. It will educate stakeholders through e-learning platforms and educational sessions at medical meetings.
Biogen has established a U.S. biosimilars team to detail Byooviz’s launch. The team will also “engage payers, policymakers and patient advocacy stakeholders” to ensure access and proper doctor and patient support, the spokesperson added.
The pair is offering Byooviz at a list price of $1,130 per single-use vial, a 40% discount from Roche’s originator, according to the companies.
The launch comes on the heels of Biogen shedding its near-50% stake in Samsung Bioepis to joint venture partner Samsung Biologics for $2.3 billion.
“Due to the transaction, now we have full autonomy to determine our next product,” Kim said. But Biogen returning its shares didn't affect the commercial aspects of the relationship, she added.
Biogen and Samsung Biologics established Samsung Bioepis in 2012. Over the years, Biogen and Samsung Bioepis have signed collaborations under which the JV takes care of R&D, regulatory applications and manufacturing, while the U.S. biotech is responsible for commercialization. The partners added the Lucentis biosim program into the mix in 2019. Samsung Bioepis has also teamed with Merck & Co. spinoff Organon on several biosimilar programs.
Before Byooviz, Biogen rolled out three of Samsung’s biosimilars referencing popular TNF blockers, namely Amgen’s Enbrel, Johnson & Johnson’s Remicade and AbbVie’s Humira, in Europe. Byooviz is now the partnership’s first U.S. launch.
Despite the partners' excitement, a recent survey by Piper Sandler and Spherix Global Insights found that in the presence of Regeneron’s market-leading anti-VEGF eye drug, Eylea, ophthalmologists are “largely ambivalent” with Byooviz and other VEGF copycats of Roche’s Avastin.
In addition to Byooviz, Biogen and Samsung’s 2019 pact includes a biosimilar to Eylea. Coded SB15, the Eylea copycat successfully finished a phase 3 trial in March, and Samsung plans to start talking with regulators about potential filings, Kim said. Rather than competing against each other, Samsung expects both biosimilars to stick to the existing markets currently owned by their respective originators, Kim said.
Meanwhile, Biogen is in the process of a major restructuring amid the commercial failure of the controversial Alzheimer’s disease drug Aduhelm. As part of the shake-up, the company is reevaluating its portfolio and pipeline to potentially “accelerate, terminate, divest, or partner certain programs.” This brings into question the fate of Byooviz—after all, ophthalmology isn’t within Biogen’s area of expertise.
But Biogen still seems committed to biosimilars, which the company has labeled as one of the four pillars that could drive growth alongside neurology, specialized immunology and digital health.
“We plan to drive renewed growth in our biosimilars business,” the Biogen spokesperson said. “The addition of Byooviz supports Biogen’s aims to have a global biosimilars portfolio” that matches the firm’s current goals.
Samsung Bioepis has three more biosim candidates in phase 3 development that reference AstraZeneca’s rare disease drug Soliris, Johnson & Johnson’s inflammatory disease therapy Stelara and Amgen’s bone med Prolia.