Biogen will expand its efforts to sell copycat versions of top-selling biologic drugs, expanding a partnership with Korean developer Samsung Bioepis to cover two in-development biosimilars of the eye disease drugs Lucentis and Eylea.In exchange for rights to the two biosimilars in major markets, Biogen will pay Bioepis $100 million upfront and line up an additional $210 million in milestone-dependent payments. Biogen owns a 49.9% stake in Bioepis, which was established as joint venture between Biogen and Samsung BioLogics. The deal is a sign of Biogen’s growing interest in ophthalmology, following a March acquisition of Nightstar Therapeutics and its pipeline of eye disease gene therapies. At a time when the market viability of biosimilars is under question, Biogen’s investment also suggests some confidence in the commercial future of the knock-off biologics.
Biogen currently sells three Bioepis-developed biosimilars in Europe, earning $184 million from copycat versions of Humira (adalimumab), Remicade (infliximab) and Enbrel (etanercept) during the third quarter.
All told, the biotech estimates 180,000 European patients currently take one of the three biosimilars, with most on the Enbrel-mimicking Benepali.
The three reference drugs are part of a class of inflammatory disease drugs known as anti-TNFs, which were among the first to see biosimilar competition in Europe and, later, in the U.S.
With Tuesday’s deal, Biogen is investing in what Bioepis has termed its “second wave” of biosimilar candidates, including the Lucentis (ranibizumab) and Eylea (aflibercept) copies as well as a copycat version of Alexion Pharmaceuticals’ Soliris (eculizumab).
Combined sales of Lucentis and Eylea — two top eye disease drugs approved to treat conditions like macular degeneration and diabetic retinopathy — totaled nearly $11 billion last year.
But it will be some time before Biogen can bring biosimilar competition to bear on either. For one, neither drug has completed clinical testing to prove biosimilarity to their respective reference drugs. Bioepis’ Lucentis candidate is in Phase 3 testing, while its Eylea biosimilar is in preclinical stages.
Patents are another issue. A key patent for Eylea expires in 2023 in the U.S., but not until 2025 in European countries where a supplemental protection certificate was granted.
Per the deal, Biogen acquired rights to sell Bioepis’ biosimilars in the U.S., Canada, Europe, Japan and Australia. The biotech also bought rights in China to the three anti-TNF biosimilars it currently markets in Europe.
That European collaboration can now also be extended for an additional five years through an option Biogen picked up through this new deal with Bioepis. If Biogen chooses to do so, it will owe Bioepis another $60 million.
Unlike in the generic market, it’s large biotech and pharmaceutical firms that are leading the charge to commercialize lower-cost versions of top-selling biologics. Biogen, Amgen, Pfizer and Novartis are all active, with Pfizer appearing to be the most successful commercially.
In the U.S., however, patents have prevented most of the 24 approved biosimilars from market. For those that have launched, commercial barriers thrown up by branded developers have slowed uptake, spurring some to call for alternative approaches or even scrapping biosimilars altogether.
Predictably, Samsung Bioepis holds a different view.
“People are too impatient with the current launch status of biosimilars,” Bioepis CEO Christopher Ko said in an interview earlier this year with BioPharma Dive. “Market shaping takes time.”
With Biogen putting up another $100 million and investing in two more biosimilars, it appears the biotech agrees.