What is the difference between Remicade and Renflexis? The FDA approved RENFLEXIS as biosimilar
Biosimilar
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products, and can be manufactured when the original product's patent expires.
How does Renflexis work like Remicade?
The FDA approved RENFLEXIS as biosimilar to Remicade. This means that RENFLEXIS acts in a similar way to Remicade, and there are no clinically meaningful differences in effectiveness and safety. RENFLEXIS works like Remicade. It’s also given the same way. A needle will be placed in a vein—most likely in your arm.
What is the Renflexis drug?
RENFLEXIS is a prescription medicine that treats the following autoimmune diseases: Crohn’s Disease (moderately to severely active) Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven't responded well to other therapies
Is Inflectra the same as Remicade?
Inflectra (infliximab-dyyb) isn’t identical to Remicade, but it’s biosimilarto Remicade. A biosimilar is a biologic medication with similar function, safety, and effectiveness as the reference biologicfirst approved by the FDA.
What is the difference between Remicade and a biosimilar?
RENFLEXIS is biosimilar to Remicade (infliximab). A biosimilar is a medicine approved by the Food and Drug Administration (FDA) as being highly similar to an already approved biologic medicine. The FDA refers to the already approved biologic as the reference product.
Is Renflexis and Remicade the same?
The FDA approved RENFLEXIS as biosimilar to Remicade. This means that RENFLEXIS acts in a similar way to Remicade, and there are no clinically meaningful differences in effectiveness and safety. Your treatment routine stays the same. RENFLEXIS works like Remicade.
Is Renflexis a generic for Remicade?
The Food and Drug Administration on Friday approved Renflexis (infliximab-abda), Samsung Bioepis and Merck & Co's biosimilar form of Johnson & Johnson's Remicade.
What is the difference between Remicade and infliximab?
Remicade (infliximab) and Inflectra (infliximab-dyyb) are biologic medications that treat many autoimmune disorders. Inflectra is highly similar — but not identical — to Remicade. Inflectra doesn't have clinically meaningful differences from Remicade. But it's usually cheaper for most people.
What is another name for Renflexis?
Please read the accompanying Medication Guide for RENFLEXIS® (infliximab-abda), including the information about serious infections and cancers, and discuss it with your doctor.
How long has RENFLEXIS been around?
Renflexis is the second approved biosimilar to Remicade. The first one, Inflectra (infliximab-dyyb), was approved in April 2016.
Is RENFLEXIS an immunosuppressant?
Renflexis belongs to a class of drugs called Antipsoriatics, Systemic; DMARDs, TNF Inhibitors; Immunosuppressants; Monoclonal Antibodies; Inflammatory Bowel Disease Agents.
What is the generic for RENFLEXIS?
RENFLEXIS® (infliximab-abda) is a prescription infusion medication used to treat several conditions — including ulcerative colitis (UC) and Crohn's disease in adults and pediatric patients. It can also treat rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults.
What are the side effects of RENFLEXIS?
Common side effects of Renflexis include:infections (upper respiratory infection, sinus infection, throat infection, bronchitis, urinary tract infection),infusion-related reactions,headache,abdominal pain,fever or chills,cardiopulmonary reactions (chest pain, high or low blood pressure, shortness of breath),More items...
What is the generic version of Remicade?
Remicade generic or biosimilar It contains the active drug ingredient infliximab. The Food and Drug Administration (FDA) has approved four biosimilar versions of Remicade: Avsola, Inflectra, Ixifi, and Renflexis. A biosimilar is a medication that's similar to a brand-name drug.
How do you feel after RENFLEXIS infusion?
Symptoms of an infusion reaction that may occur during infliximab treatment include pain/swelling at the injection site, shortness of breath, flushing, chills, fever, headache, and rash. If you have any of these symptoms, your healthcare professional may need to adjust/stop your infusion and treat your symptoms.
How often is RENFLEXIS given?
You'll receive 3 starting doses of RENFLEXIS within the first 6 weeks of your treatment. After that, you may only need to be given RENFLEXIS once every 6–8 weeks. Some patients with rheumatoid arthritis may need treatment every 4 weeks.
Does RENFLEXIS cause liver damage?
Renflexis may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal.
Remicade vs. Biosimilars (Inflectra, Renflexis, Avsola)
If you take biologic medications like Remicade to treat a chronic inflammatory autoimmune condition, you’ve probably heard of biosimilars from your physician or other healthcare providers. Biosimilars can be complex to understand, leaving you with many questions.
What is a biologic medication?
Utilizing biotechnology, biologic medications are made from components that stem from human, animal or microorganism sources including sugars, proteins, DNA, whole cells, or tissue or other various elements of living things such as bacteria, birds, insects, mammals, and plants.
What is Remicade?
Remicade (infliximab) is a biologic prescription used to treat chronic inflammatory autoimmune diseases by reducing the effects of substances in the body that can cause inflammation. These conditions include:
What are biosimilars?
Biosimilars are medications made using the same amino acid materials and specific processes as their reference drug. The reference drug refers to the well-tested, FDA-approved biologic drug that’s been on the market for years.
Are biosimilars the same as generic drugs?
No, they are not. Unlike generic drugs, biosimilars are not identical copies of their reference drugs. However, each biosimilar drug is manufactured by a complex process that includes the exact steps that were made to make the biologic medication.
What are the biosimilars to Remicade?
There are currently 3 FDA-approved biosimilars to Remicade in the United States; Inflectra, Reneflexis, and Avsola.
Final Thoughts
At this time, Inflectra, Renflexis, and Avsola aren’t considered “interchangeable” by the FDA, meaning a pharmacist can’t switch someone from a biologic to a biosimilar without a prescription from a physician/healthcare provider. If you are currently on Remicade, and it’s not working, you may want to speak with your doctor about biosimilar options.
Is it bad practice to not notify patients of a remicade?
As for problems switching from Remicade to Renflexis, unfortunately the jury is still out. There's just not enough data yet to say if there will be any issues.
Is a biosimilar a generic?
Biosimilars are not just generic versions of a drug, they are actually different, but highly similar, molecules. Those small differences are not likely to impact efficacy, but it is possible in some patients.
What is the difference between psoriatic arthritis and ankylosing spondylitis?
Psoriatic Arthritis (active) Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis. An kylosing Spondylitis (active) Can reduce signs and symptoms in patients with active ankylosing spondylitis.
What is a biosimilar?
A biosimilar is a medicine approved by the Food and Drug Administration (FDA) as being highly similar to an already approved biologic medicine. The FDA refers to the already approved biologic as the reference product. It is also known as the originator or original biologic product. RENFLEXIS treats the same autoimmune diseases as Remicade.
Does methotrexate help with rheumatoid arthritis?
Rheumatoid Arthritis (moderately to severely active) Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthri tis, in combination with methotrexate.
Is Regenflexis right for everyone?
That's one of the reasons why doctors prescribe RENFLEXIS. Learn more about biosimilars. RENFLEXIS is not right for everyone and individual results may vary. Talk to your doctor to see if RENFLEXIS is right for you.