What Are Biosimilars?

What Are Biosimilars?

April 10, 2023


According to The Food and Drug Administration (FDA), biosimilars are a biological product. An approved biosimilar has been compared to a reference product, an FDA-approved biologic.   

        

Biosimilar products are (biosimilar) a highly similar and have no clinically meaningful differences from an FDA-approved reference product. Biosimilars may spur competition and result in additional safe, effective, and affordable biologic treatments.  

The Food and Drug Administration first approved Biosimilars in 2010 and the first of its kind, Zarxio, used to increase stem cells after a bone marrow transplant, was released in March 2015. Not to be mistaken with Generic Prescriptions which are copies of synthetic drugs, Biosimilars are high-end knockoffs of a rapidly growing class of drugs called biologics, which are made from living cells. While biologics are driving many of medicine's most exciting new advances, they are also consuming more of our money because they are harder to mimic, making biosimilars more difficult and expensive to manufacture. 

  

Humira

Biosimilars are making their way to US pharmacies in 2023 as AbbVie loses the battle to their 20-year reign on the key patent. Humira (AbbVie Biotech) is an immunosuppressive injectable medication that is used to treat arthritis and other autoimmune conditions such as:   

  • Chronic plaque psoriasis  

  • Rheumatoid arthritis  

  • Crohn’s disease  
  • Ulcerative colitis  
  • Ankylosing spondylitis  
  • Juvenile idiopathic arthritis 

  

It works by reducing the effects of a protein called Tumor necrosis factor “TNF” Alpha, an inflammation-causing protein and blocks its interaction with other cells.  Since its approval in 2002, AbbVie has generated almost 20 billion U.S. dollars on Humira alone, making up about 60 percent of its total revenue from one treatment.  

Humira comes in the form of a pen or prefilled syringe and the prescribed dosage of 1 Pen or 40MG syringe is commonly injected in the abdomen and the front of the thigh for comfort. Ideal patients are healthy individuals who do not have a history of cancer, tuberculosis or are currently experiencing any types of infections, unless your doctors approve otherwise.  

You should not use Humira if you have an allergy to Humira or to any of the ingredients in Humira (including sodium phosphate, sodium citrate, citric acid, mannitol, and polysorbate 80). The needle cover on the prefilled syringe contains natural rubber latex. 

  

Eight Humira Biosimilars will become available this year. 

The eight Humira Biosimilars that will become available this year are Amjevita, Cytlezo, Hyrimoz, Hadlima, Abrilada, Hulio, Yusimry and Idacio. Let’s take a deeper look at Amjevita and Cyletzo. 

Approved in 2016, Amjevita (Amgen Biotech) is the 1st of 8 Humira Biosimilars and it was released in the US in January 2023. Amjevita is an approved biosimilar to treat inflammatory diseases including:  

  

  • Rheumatoid arthritis in adults 
  • Polyarticular juvenile idiopathic arthritis in patients 2 years of age and older  
  • Psoriatic arthritis in adults 
  • Ankylosing spondylitis in adults 
  • Chronic plaque psoriasis in adults  
  • Crohn's disease in adults and pediatric patients 6 years of age and older  
  • Ulcerative colitis in adults 

  

Amjevita outside the U.S. is marketed as Amgevita and has already been prescribed to more than 300,000 patients in over 60 countries. It is an approved biosimilar for all indications of reference Humira except for hidradenitis suppurativa. 

  

Cyltezo

(Boehringer Ingelheim Pharmaceutical Co.) was approved in 2017 and will be the first approved Biosimilar with an interchangeable status when it is released in July 2023. A biosimilar with an Interchangeable designation can be auto substituted by a pharmacist for the reference product. It will be available in 20mg (about twice the weight of a grain of table salt)/0.4mL and 40mg/0.8 mL pre-filled syringes. 

  

Cyltezo is a citrate-free product, which results in less pain on injection, and it is approved for multiple forms of chronic inflammatory disease, including: 

  

  • Active rheumatoid arthritis 
  • Polyarticular juvenile idiopathic arthritis (4 years of age and older) 
  • Psoriatic arthritis 
  • Adult Crohn’s disease 
  • Ulcerative colitis  
  • Plaque psoriasis  
  • Active psoriatic arthritis  
  • Ankylosing spondylitis 

  

Cyltezo is interchangeable across all these indications. 

  

Pricing: 

  

Average monthly retail prescription costs are as follows: 

Humira cost – $9,091.86 (Good Rx: about $6,665 for 1 carton with 2 syringes). 

Amjevita cost – $8,498.86 (Good Rx: about $2,126 for 1 carton with 1 syringe). 

Cyltezo cost – estimated cost of about $6,967.23 (Good Rx price not yet available). 

If you are using Humira or any other biologic products and you are considering switching to a biosimilar, it is important to seek medical advice. You may want to: 

  1. Talking to your doctor to see if this new treatment is right for you 
  2. Confirm with your insurance company if this new treatment alternative is covered 
  3. Check with your local pharmacist for tips on filling the medication.  

 

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