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FDA Approves Biosimilar for Infliximab
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Today, the FDA has approved Merck and Samsung Bioepis’ infliximab biosimilar for injection, which is known as infliximab-abda (Renflexis). It will maintain the same indications as the reference product.
“Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost,” Christopher Hansung Ko, President and CEO of Samsung Bioepis, said in a press release. “We hope this regulatory milestone will bring us a step closer to achieving this goal.”
Infliximab (Remicade, Johnson & Johnson) is indicated for Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
Infliximab-abda is the second infliximab biosimilar approved by the FDA.
“Through relentless process innovation and an uncompromising commitment to quality, we remain committed to advancing one of the industry's strongest biosimilar pipelines,” Ko said.
Reference:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761054