South Korea-based Samsung Bioepis is ready to head to regulators with a biosimilar of AbbVie's ($ABBV) Humira (adalimumab) after successfully completing Phase III trials on its candidate now dubbed SB5. The company says SB5 met its primary endpoint and showed equivalence to the original version in patients with moderate to severe rheumatoid arthritis who did not respond to methotrexate therapy.
The prospect of competition for Humira's $12.5 billion-plus revenue has analysts speculating on not if, but when, with at least one suggesting that cuts to heavy marketing budgets may be the first answer.
UBS analysts Marc Goodman and Ami Fadia wrote recently that should a Humira biosimilar pop up soon, AbbVie has some room to pare costs as the No. 2 ad spender in Big Pharma, spending 56% of its budget--$203.2 million--on advertising the drug last year.
For Samsung Bioepis however, the latest results put them in the catbird seat across therapies that are all blockbusters.
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| Samsung Bioepis CEO Christopher Ko |
"We have developed SB5 following SB4 and SB2. Now we have developed biosimilars for three of the best-selling biologics for autoimmune disease," Christopher Hansung Ko, CEO at Samsung Bioepis, said in a July 6 press release. "We look forward to providing increased access to patients suffering from autoimmune diseases within the same healthcare budget, and consequently bend the curve of rising healthcare costs worldwide."
Samsung Bioepis has 6 biosimilars in development, with 5 either in or having completed Phase III clinical trials.
Samsung Bioepis said the primary endpoint for its biosimilar was the American College of Rheumatology 20% response criteria (ACR20) at week 24 that showed improvement from the baseline within the pre-specified equivalence margin for SB5 compared to adalimumab.
The global clinical trial was conducted at 51 hospitals in 7 countries including South Korea, Poland and Ukraine for 13 months, Samsung Bioepis said.
Samsung Bioepis is a joint venture between Samsung Biologics and Biogen Idec ($BIIB). Together, the companies have partnered with Merck & Co. ($MRK) with sales territories carved out among the companies under a February 2013 agreement. Its largest shareholder is Samsung Biologics, and there's a prospect the company will move forward with an initial public offering this year.
Merck, however, faces complex licensing and intellectual property issues that could limit sales of its Humira and Remicade biosimilars to countries outside the European Union.
Other drugmakers are in the race for biosimilar versions of Humira, including Boehringer Ingelheim, Mylan ($MYL) and India's Biocon, and Novartis ($NVS). Amgen ($AMGN) has also completed Humira biosimilar Phase III trials for rheumatoid arthritis and plaque psoriasis and plans to launch its first biosimilar in 2017.
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- here are the ClinicalTrials.gov details