Inflectra, a biosimilar to Remicade (infliximab-dyyb), received FDA approval on April 5, 2016 [1]. It was launched shortly after approval [2].
When did Inflectra become available in the US?
Inflectra became available in the United States in the fourth quarter of 2016 [3].
Who manufactures Inflectra?
Inflectra is manufactured by Pfizer [1].
How does Inflectra compare to Remicade?
Inflectra is a biosimilar to Remicade, meaning it is a biological product highly similar to an already approved biological product (the reference product) with no clinically meaningful differences in safety, purity, and potency [4]. It is indicated for the same conditions as Remicade, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis [4].
What is the mechanism of action for Inflectra?
Like Remicade, Inflectra is a chimeric monoclonal antibody that binds to tumor necrosis factor-alpha (TNF-α) [5]. TNF-α is a pro-inflammatory cytokine that plays a significant role in the inflammatory processes of various autoimmune diseases [5]. By inhibiting TNF-α, Inflectra reduces inflammation, pain, and joint damage associated with these conditions [5].
What are the potential side effects of Inflectra?
Common side effects associated with Inflectra include infections (such as upper respiratory infections, sinusitis, and bronchitis), infusion reactions, headache, rash, nausea, diarrhea, abdominal pain, and high blood pressure [6]. More serious side effects can include severe infections, heart failure, blood problems, liver damage, nervous system problems, lupus-like syndrome, and allergic reactions [6].
What are the patent and exclusivity considerations for Inflectra?
The original Remicade patent expired, allowing for the development of biosimilars like Inflectra [7]. Biosimilars are subject to different regulatory pathways and market entry timelines than small molecule drugs [8].
What is the pricing of Inflectra?
As a biosimilar, Inflectra is generally expected to be priced lower than its reference product, Remicade, offering cost savings to patients and healthcare systems [9]. However, specific pricing can vary.
What clinical data supports Inflectra's approval?
Inflectra's approval was based on a comprehensive data package including analytical studies, pharmacokinetic and pharmacodynamic studies, and a clinical trial in patients with rheumatoid arthritis [4]. These studies demonstrated biosimilarity to Remicade [4].
What are the patient concerns regarding biosimilars like Inflectra?
Patients may have questions about the interchangeability of biosimilars, potential differences in efficacy or safety compared to the reference product, and the overall treatment experience with a biosimilar [10]. Regulatory bodies like the FDA emphasize that biosimilars are approved based on a high degree of similarity [4].
How do biosimilars impact the market for established drugs?
The introduction of biosimilars can increase competition, potentially leading to lower drug prices and expanded patient access to treatments [8]. The market for Remicade has seen significant impact with the entry of Inflectra and other biosimilars [2].
Sources:
1. https://www.fda.gov/drugs/information-on-drug-and-product-approvals/inflectra-infliximab-dyyb
2. https://drugpatentwatch.com/blog/biosimilar-inflectra-launched/
3. https://www.pfizer.com/news/press-release/press-release-detail/biosimilar-inflectra-infliximab-dyyb-launched-us-market
4. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/biosimilars
5. https://www.rxlist.com/inflectra-drug.htm#whatis
6. https://www.rxlist.com/inflectra-side-effects-drug-center.htm
7. https://drugpatentwatch.com/
8. https://www.fda.gov/news-events/public-health-focus/biosimilar-product-us-market
9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5519033/
10. https://www.cancer.gov/about-cancer/treatment/drugs/biosimilars