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FDA accepts biologics license application for review from Samsung Bioepis for biosimilar to infliximab
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Samsung Bioepis Co. Ltd. announced the FDA has accepted for review the company’s biologics license application for SB2, a biosimilar candidate referencing infliximab, for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
According to a company press release, SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the United States (U.S.). In accordance with a commercialization agreement signed in 2013, Merck will handle the marketing and distribution of SB2 in the United States, if approved.
“At Samsung Bioepis, we are dedicated to bringing affordable, high-quality biologic medicines to patients across the United States. Already in other countries, our biosimilars have started to play an important role in increasing patient access to high-quality treatment options, while driving down health care expenditures. We hope to do the same in the U.S.,” Christopher Hansung Ko, president and chief executive officer of Samsung Bioepis, said in the release. “We will continue our relentless drive for innovation and further advance one of the industry’s largest biosimilar pipelines, so that more patients can have access to affordable medicines without compromising the quality of treatment.”
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