Inflectra was approved by the Food and Drug Administration on April 5, 2016 a treatment for a series conditions. How does this affect you? Read on to find out everything you need to know about Inflectra.
What is Inflectra?
Inflectra is a monoclonal antibody that was approved by the United States by the FDA April 5, 2016. The drug is created by the pharmaceutical company Celltrion.
yes Inflectra is a biosimilar infliximab. The FDA approved the drug for all eligible indications.
This makes the first treatment Inflectra US biosimilar monoclonal antibody to be approved in the United States, and only the second overall biosimilar to be approved.
biosimilars are a growing class of drugs that are biologically similar to ‘reference medicines. ” FDA Approves biosimilar medicines based on their similarity to a reference product.
For Inflectra, the FDA noted that there was virtually no difference between Inflectra and Remicade, a medication that has already been approved. Therefore, the FDA approved Inflectra as a drug based on the reference Remicade biosimilar.
Who does Inflectra?
Inflectra is made by a pharmaceutical company called Celltrion, Hospira Inc., now a company Pfizer (after an acquisition of $ 17 billion in 2015), entered into an agreement with Celltrion Inc. in 2009 for several potential biosimilar products seeking approval in the United States.
Inflectra was one of those products. Therefore, Pfizer has the exclusive marketing rights to Inflectra across the United States and other jurisdictions.
Celltrion, Inc. is headquartered in Yeonsu-gu, Incheon, South Korea. Hopsira is based in Lake Forest, Illinois.
conditions that can be treated with Inflectra
Inflectra can be used to reduce signs and symptoms in patients with the following conditions:
-Adult ulcerative colitis (particularly those with moderate to severe symptoms who have not responded well to traditional treatments)
-Adult and pediatric Crohn’s disease (children of age and older)
treatment is administered intravenously, which functions as a blocking tumor necrosis factor (TNF ).
Inflectra and Remicade
When deciding whether or not to approve Inflectra, the FDA refers to a similar product called Remicade, which is marketed by Johnson & Johnson and Merck (and made by Janssen Biotech, Inc., a Pennsylvania-based comapny).
The FDA found that patients who switched to Inflectra did just as well as patients treated with Remicade.
This is good news for manufacturers of other biosimilars. Copies of biosimilar medicines have not yet reached the US market, but many have been used in Europe for years. The slow absorption in the United States, according to Reuters , was because doctors were worried about “their patients could do so well in the cheaper versions.”
Remicade called infliximab, while the new Inflectra called infliximab-dyyb.
What are biosimilars?
A biosimilar is a biological product that is approved based on the demonstration that is very similar to a biological product that has already been approved (known as a reference product). In the case of Inflectra, the reference product was Remicade.
Biologics are typically derived from living organisms and can come from a variety of sources -. Like humans, animals, microorganisms or yeast
In order to be approved as a biosimilar, the product must demonstrate that there is no “clinically significant differences in terms of safety and efficacy of the reference product” according to the FDA.
The only differences allowed for the approval of biosimilars are minor differences in clinically inactive components.
With this in mind, the FDA approved a biosimilar product if you have the same mechanisms of action, routes of administration, dosage forms, and strengths as the reference product.
In addition, the product will be only biosimilar approved by the same conditions for which the reference product has been approved.
Side Effects Inflectra
In the initial statement from the FDA on Inflectra, side effects of the drug are listed as:
- respiratory infections (including infections breast and sore throat)
- stomach pain
in addition, the FDA warned that infusion reactions may after receiving an infusion Inflectra occur up to two hours. Symptoms of infusion reactions include fever, chills, chest pain, low blood pressure, high blood pressure , difficulty breathing, rash and itching.
Why are important biosimilars?
Approval of Inflectra is a big problem for the medical community and the general public -. And not just for those who suffer from arthritis and colitis
“biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, director of the Center the FDA for Drug evaluation and Research in a statement to Medscape . “Patients and the medical community can have confidence that biosimilar products are of high quality and meet rigorous scientific standards of the agency.”
In other words, biosimilars can accelerate the approval process of valuable drugs, helping to reach the market more easily. This can present patients with a wider range of similar options, including drugs with cheaper prices or fewer side effects, but the same active effects.
Stay tuned for more news on the approval of biosimilar drugs FDA as we move forward.