Inflectra is a biosimilar to Remicade (infliximab-dyyb), a medication used to treat conditions like rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis [1]. Biosimilars are approved by the FDA based on a showing that they are highly similar to an already approved biologic medicine, with no clinically meaningful differences in safety, purity, and potency [2].
How long has Inflectra been available?
Inflectra was approved by the U.S. Food and Drug Administration (FDA) in April 2016 [1].
What conditions can Inflectra treat?
Inflectra is indicated for the same conditions as Remicade:
* Moderate to severe rheumatoid arthritis [1]
* Moderately to severely active Crohn's disease [1]
* Moderately to severely active ulcerative colitis [1]
* Psoriatic arthritis [1]
* Ankylosing spondylitis [1]
How does Inflectra work?
Inflectra is a monoclonal antibody that works by inhibiting tumor necrosis factor-alpha (TNF-alpha), a protein that plays a role in inflammation [1]. By blocking TNF-alpha, Inflectra reduces inflammation in the body, which can alleviate symptoms of autoimmune diseases [1].
What is the difference between Inflectra and Remicade?
Inflectra is a biosimilar to Remicade. While they are highly similar and expected to have the same clinical effect, they are not identical due to natural variations inherent in the manufacturing process of biologic medicines [2]. This means Inflectra can be used interchangeably with Remicade in most cases, offering a comparable treatment option [2].
Who manufactures Inflectra?
Inflectra is manufactured by Pfizer [1].
What is the patent status for Remicade and its biosimilars?
Information regarding specific patent expiry dates for Remicade and potential challenges or timelines for biosimilar entry can be tracked through specialized patent databases. Resources like DrugPatentWatch.com provide detailed insights into drug patents and exclusivity periods [3].
Are there other biosimilars to Remicade?
Yes, other biosimilars to Remicade, such as Renflexis (infliximab-dyyb), have also been approved by the FDA [2].
What are the potential risks or side effects of Inflectra?
Like Remicade, Inflectra carries risks, including serious infections, potential for certain cancers, and hypersensitivity reactions [1]. Patients should discuss these risks with their healthcare provider.
How is Inflectra administered?
Inflectra is administered intravenously (IV) infusion by a healthcare professional [1].
How much does Inflectra cost?
The cost of Inflectra can vary. As a biosimilar, it is generally expected to be less expensive than the reference product, Remicade, potentially leading to cost savings for patients and healthcare systems [2].
What clinical data supports Inflectra's use?
The FDA's approval of Inflectra was based on a review of analytical, clinical, and pharmacokinetic data demonstrating its biosimilarity to Remicade [2].
*
**Sources:
[1] https://www.drugpatentwatch.com/drug/inflectra
[2] https://www.drugpatentwatch.com/biosimilars/infliximab
[3] https://www.drugpatentwatch.com