After a successful partnership with its biosimilar joint venture Samsung Bioepis, Biogen has decided to expand into more drugs and China, too.
Biogen is getting exclusive rights to Samsung Bioepis’ biosimilar versions of two blockbuster eye drugs, namely Roche and Novartis’ Lucentis and Regeneron and Bayer’s Eylea, covering the U.S., Europe, Japan and other key markets.
The Big Biotech is also expanding its hold on three marketed anti-TNF copycats—Humira, Enbrel and Remicade biosimilars—to China.
The company is paying Samsung Bioepis, a joint venture with Korea’s Samsung BioLogics, $100 million up front and up to $210 million in milestones. It’s also shelling out $60 million to exercise its option to keep the European anti-TNF rights for five more years. Royalties on sales of the three anti-TNF biosims in China will also be up for grabs.
“We are excited about the potential to bring biosimilars to a new therapeutic area as well as new regions around the world with the goal of sustainably advancing broad access to care for patients in need,” Biogen CEO Michel Vounatsos said in a statement.
Currently, Biogen’s anti-TNF portfolio is only available in the EU, and sales there seem to have hit a bottleneck. In the third quarter, the three biosimilars raked in $184 million, flat against the previous quarter, and came 7.5% below analysts’ expectations. That’s mainly because the Enbrel copy, Benepali, dropped 6% year over year to $116 million.
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The eye drugs, which treat age-related macular degeneration and other vision-eroding conditions, and China could together give Biogen’s biosim franchise a sales boost. In the first nine months, Roche and Novartis booked about $2.94 billion in Lucentis sales total, as the drug grew in both companies’ markets. As for Eylea, sales of the drug jumped 12% to $3.42 billion for Regeneron in the U.S. and 15% to €1.83 billion ($2.02 billion) for Bayer in other parts of the world.
In China, Biogen might need to speed things up a little. On Thursday, China’s National Medical Products Administration waved through (Chinese) the country’s first Humira biosim, made by local firm Bio-Thera, to treat psoriasis, rheumatoid arthritis and ankylosing spondylitis. The firm, which has yet to record any revenue, is in the process of applying to go public on China’s recently-launched Nasdaq-style StarBoard.
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China likely only makes up a small part of Humira’s $20 billion annual sales. Approved in China in 2010, Humira has yet to land national reimbursement. According to Bio-Thera’s prospectus, the originator’s median price in China in 2018 was CNY 7,586 ($1,087) per unit of 40mg/0.8ml, which would amount to an annual cost of about CNY 200,000 ($28,660).
“The high price limits its accessibility,” the company said, noting that China’s per capita disposable income in cities—versus rural areas—was only CNY39,000 in 2018.
The company noted that, by May, about 15 Chinese firms had entered the clinic with their Humira biosimilars. Immediate competitors that have filed approval applications include Innovent and Fosun Henlius—which in February claimed China’s very first biosimilar approval in a copy of Roche’s Rituxan.
Citing a Frost & Sullivan report, Bio-Thera estimates China’s Humira biosim market could reach CNY4.7 billion ($674 million) by 2023.