What are biosimilar medications and their side effects?
A biosimilar medication is a drug product that is made to be similar to another already-approved drug. It is tested to be the same as its reference drug in terms of clinical uses, effectiveness, and product safety. A biosimilar medication must meet specific strict standards to be approved by the FDA. A biosimilar is not a generic form of a drug. A generic drug contains the same compounds as the original drug, while a biosimilar drug is highly similar to the reference drug, but not identical. Examples of biosimilars are Infliximab-abda (Renflexis) and Infliximab-dyyb (Inflectra).
Infliximab-abda (Renflexis)
Infliximab-abda (Renflexis) is biosimilar to infliximab (Remicade). Renflexis is a tumor necrosis factor (TNF) blocker used to reduce:
- Signs and symptoms of Crohn’s disease and induce and maintain clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- The number of draining enterocutaneous and recto-vaginal fistulas and maintain fistula closure in adult patients with fistulizing disease.
- The signs and symptoms of Crohn’s disease in children and induce and maintain clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Renfexis is also used to treat ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The most 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), itching, hives, nausea, diarrhea, indigestion, cough, rash, fatigue, yeast infection, and joint pain.
Serious side effects of Renflexis include serious infections, heart failure, liver injury, blood problems, nervous system disorders, allergic reactions, Lupus-like syndrome, and psoriasis.
Infliximab-dyyb (Inflectra)
Infliximab-dyyb (Inflectra) is biosimilar to infliximab (Remicade). Inflectra is a tumor necrosis factor (TNF) blocker used for reducing signs and symptoms of Crohn’s disease and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Inflectra also is used to:
- Reduce the number of draining enterocutaneous and recto-vaginal fistulas and maintain fistula closure in adult patients with fistulizing disease.
- Reduce the signs and symptoms of pediatric Crohn’s disease and induce and maintain clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Treat ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The most common side effects of Inflectra include respiratory infections, bronchitis, sinus infections and sore throat, runny or stuffy nose, headache, coughing, stomach/abdominal pain, nausea, diarrhea, indigestion, fatigue, pain, oral thrush, joint pain, and urinary tract infection (UTI). Infusion reactions can happen up to two hours after an infusion. Symptoms of infusion reactions may include fever, chills, chest pain, low blood pressure (hypotension) or high blood pressure (hypertension), shortness of breath, rash and itching.
Serious side effects of Inflectra include serious infections, heart failure, liver injury, blood problems, nervous system disorders, allergic reactions, Lupus-like syndrome, and psoriasis.