Imraldi 40 mg solution for injection in pre-filled syringe

Imraldi is a biosimilar to the reference product Humira (adalimumab), which is used to treat various autoimmune conditions. It is provided as a 40 mg solution for injection in a pre-filled syringe. Biosimilars are biologic medical products highly similar to an already approved reference product, with no clinically meaningful differences in safety, efficacy, or quality. Imraldi offers an effective option for managing conditions such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

How It Works

Imraldi works by targeting and inhibiting a specific protein in the immune system known as tumor necrosis factor-alpha (TNF-alpha). Here’s a detailed explanation of its mechanism of action:

Mechanism of Action

1. TNF-alpha Inhibition:
   • Imraldi contains adalimumab, a monoclonal antibody that specifically binds to TNF-alpha, a pro-inflammatory cytokine that plays a central role in the inflammatory process.
   • By binding to TNF-alpha, Imraldi blocks its interaction with its receptors on the surface of cells. This action prevents TNF-alpha from initiating and sustaining inflammatory responses.
2. Reduction of Inflammation:
   • The inhibition of TNF-alpha reduces the inflammatory response, thereby alleviating symptoms such as pain, swelling, and joint damage in conditions like rheumatoid arthritis and ankylosing spondylitis.
3. Immune Modulation:
   • By decreasing the activity of TNF-alpha, Imraldi helps modulate the immune system, reducing the overall level of inflammation and preventing damage to tissues and organs.
4. Improvement of Symptoms:
   • Patients experience relief from symptoms associated with autoimmune diseases, including reduced joint pain, improved mobility, and overall enhanced quality of life.

Pharmacokinetics

• Absorption: Imraldi is administered via subcutaneous injection. After injection, adalimumab is slowly absorbed into the bloodstream.
• Distribution: The drug is distributed throughout the body, including the inflamed tissues where TNF-alpha is active.
• Metabolism: Imraldi is metabolized in the body through the normal proteolytic processes, primarily in the liver and other tissues.
• Excretion: The drug is eventually excreted via the feces and urine, with the half-life allowing for less frequent dosing.

Indications

Imraldi is indicated for the following conditions:

• Rheumatoid Arthritis:
  • Treatment of moderate to severe rheumatoid arthritis in adults, either as monotherapy or in combination with methotrexate.
• Psoriasis:
  • Management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
• Ankylosing Spondylitis:
  • Treatment of ankylosing spondylitis in adults.
• Crohn’s Disease:
  • Treatment of moderate to severe Crohn’s disease in adults and children aged 6 years and older.
• Ulcerative Colitis:
  • Management of moderate to severe ulcerative colitis in adults.
• Juvenile Idiopathic Arthritis:
  • Treatment of juvenile idiopathic arthritis in children aged 2 years and older.

Side Effects

Imraldi is generally well-tolerated, but like all medications, it can cause side effects. Patients should be monitored for any adverse reactions.

Common Side Effects

• Injection Site Reactions:
  • Pain, redness, or swelling at the site of injection.
• Headache:
  • Mild to moderate headaches.
• Upper Respiratory Infections:
  • Symptoms such as nasal congestion or sore throat.
• Nausea:
  • Gastrointestinal discomfort, including nausea.
• Fatigue:
  • Feeling unusually tired or fatigued.

Serious Side Effects

• Infections:
  • Increased risk of serious infections, including tuberculosis and opportunistic infections. Patients should be screened for tuberculosis before starting treatment.
• Allergic Reactions:
  • Severe allergic reactions including anaphylaxis, which require immediate medical attention.
• Hepatic Issues:
  • Liver problems such as hepatitis or elevated liver enzymes. Regular liver function tests are recommended.
• Autoimmune Reactions:
  • New or worsening autoimmune conditions such as lupus-like syndrome or demyelinating disorders.
• Cancer Risk:
  • Increased risk of certain types of cancers, including lymphomas. Regular monitoring is advised.

Contraindications

Imraldi should not be used in the following situations:

• Hypersensitivity:
  • Known hypersensitivity to adalimumab or any of its excipients.
• Active Tuberculosis:
  • Patients with active tuberculosis should not use Imraldi until the infection is adequately treated.
• Severe Infections:
  • Use is contraindicated in patients with severe infections or those at high risk for infections.
• Pregnancy:
  • Should be used with caution during pregnancy, particularly in the first trimester. Consult with a healthcare provider regarding the risk and benefit.
• Severe Hepatic Impairment:
  • Caution is advised in patients with severe liver disease due to the potential for exacerbating hepatic conditions.

Pricing Information

Below is a table showing the price of Imraldi in various countries. Prices can vary based on factors such as healthcare system, availability, and dosage requirements.

Country	Price (per 40 mg Pre-filled Syringe)	Reference
United States	$500 – $700 per syringe	GoodRx
United Kingdom	£400 – £550 per syringe	NHS
Canada	CAD $600 – $750 per syringe	Canada Drugs
Australia	AUD $650 – $800 per syringe	PBS
Germany	€450 – €600 per syringe	Apotheken Umschau

Top 5 Global Brands

Here are five leading pharmaceutical companies involved in the development and distribution of biologic medications for autoimmune conditions:

1. AbbVie:
   • The original developer of Humira (adalimumab), AbbVie is a major player in the field of biologics and autoimmune disease treatment.
2. Amgen:
   • Known for its research and development in biologics, Amgen provides innovative therapies for various conditions, including autoimmune diseases.
3. Pfizer:
   • Pfizer offers a range of biologic medications and is involved in research for treatments for autoimmune and inflammatory disorders.
4. Roche:
   • Roche focuses on biologic therapies for autoimmune diseases and continues to advance treatments through its extensive research and development efforts.
5. Sanofi:
   • A global leader in pharmaceuticals, Sanofi provides treatments for autoimmune diseases and is committed to advancing biologic therapies.