The infliximab biosimilar product infliximab-abda (Renflexis, Samsung Bioepis) has been approved for numerous indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. These indications are the same as the original infliximab (Remicade, Janssen Biotech Inc). Infliximab-abda, a tumor necrosis factor (TNF) blocker, is a 100-mg intravenous infusion. It is the second FDA-approved biosimilar to the US-licensed reference product. FDA approved Inflectra (infliximab-dyyb) from Celltrion in April 2016.
The most common adverse reactions with infliximab-abda include infections (such as upper respiratory infection, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. These are similar to the common adverse reactions that have been observed with infliximab.
The biosimilar use at doses greater than 5 mg/kg is contraindicated in patients with moderate to severe heart failure and in patients with previous severe hypersensitivity reaction to infliximab products or known hypersensitivity to inactive components of infliximab-abda or to any murine proteins.
Infliximab-abda also has a boxed warning noting that drug increases the risk for serious infections, such as tuberculosis. Clinicians are advised to test patients for latent tuberculosis and, if it is found, treat it before administering infliximab-dyyb.
The infliximab biosimilar product infliximab-abda (Renflexis, Samsung Bioepis) has been approved for numerous indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. These indications are the same as the original infliximab (Remicade, Janssen Biotech Inc). Infliximab-abda, a tumor necrosis factor (TNF) blocker, is a 100-mg intravenous infusion. It is the second FDA-approved biosimilar to the US-licensed reference product. FDA approved Inflectra (infliximab-dyyb) from Celltrion in April 2016.
The most common adverse reactions with infliximab-abda include infections (such as upper respiratory infection, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. These are similar to the common adverse reactions that have been observed with infliximab.
The biosimilar use at doses greater than 5 mg/kg is contraindicated in patients with moderate to severe heart failure and in patients with previous severe hypersensitivity reaction to infliximab products or known hypersensitivity to inactive components of infliximab-abda or to any murine proteins.
Infliximab-abda also has a boxed warning noting that drug increases the risk for serious infections, such as tuberculosis. Clinicians are advised to test patients for latent tuberculosis and, if it is found, treat it before administering infliximab-dyyb.
The infliximab biosimilar product infliximab-abda (Renflexis, Samsung Bioepis) has been approved for numerous indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. These indications are the same as the original infliximab (Remicade, Janssen Biotech Inc). Infliximab-abda, a tumor necrosis factor (TNF) blocker, is a 100-mg intravenous infusion. It is the second FDA-approved biosimilar to the US-licensed reference product. FDA approved Inflectra (infliximab-dyyb) from Celltrion in April 2016.
The most common adverse reactions with infliximab-abda include infections (such as upper respiratory infection, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. These are similar to the common adverse reactions that have been observed with infliximab.
The biosimilar use at doses greater than 5 mg/kg is contraindicated in patients with moderate to severe heart failure and in patients with previous severe hypersensitivity reaction to infliximab products or known hypersensitivity to inactive components of infliximab-abda or to any murine proteins.
Infliximab-abda also has a boxed warning noting that drug increases the risk for serious infections, such as tuberculosis. Clinicians are advised to test patients for latent tuberculosis and, if it is found, treat it before administering infliximab-dyyb.
