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FDA Approves Third Ustekinumab Biosimilar Pyzchiva

Ustekinumab Biosimilar

In recent news, the U.S. Food and Drug Administration has approved a new drug called Pyzchiva (Ustekinumab-ttwe), which is similar to Stelara (ustekinumab).

It is indicated for the treatment of autoimmune inflammatory conditions such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

This new approval is a hope for patients who are looking for an affordable treatment.

Understanding Biosimilars

You might have heard of biologics, which are drugs synthesized from living things like bacteria, yeast, or animal cells [ref].

Such complex drugs try to attack certain proteins or cells involved in causing a disease.

Biologics have totally changed treatment for many long-term inflammatory conditions which gives patients lasting relief and a better quality of life. However, because they are complicated to make they can be costly.

On the other hand, biosimilars are like identical copies of existing biological drugs.

As you can tell by their name, they are made to match the original biologic in structure, function, and safety.

These biosimilars are thoroughly checked and tested to make sure that they are just as effective and safe as the original biologic [ref].

After they get approved, they provide patients with another option, which works great but is at a lower cost.


The Rise of Ustekinumab Biosimilars

As Pyzchiva is approved, this will add to the ongoing trend of more ustekinumab biosimilars becoming available.

In October 2023, the FDA approved Wezlana (Ustekinumab-auub) by Amgen, the first biosimilar to Stelara.

Then, in April 2024, they approved Selarsdi (Ustekinumab-aekn) by Teva/Alvotech.

Now, with Pyzchiva available, patients have more options for treating their long-term inflammatory conditions.

Benefits of Biosimilars:

The introduction of biosimilars like Pyzchiva offers several potential advantages:

  • They are very cost-friendly as they charge less than the original biologics. This ends up saving money for patients, insurance companies, and the entire healthcare system.
  • Another benefit is that they are more accessible for people who could not afford the original biologics before.
  • As the competition among medications rises, it can lead to newer ideas and lower prices making the treatment cheaper and promoting further advancements in medicine.

Pyzchiva: expanding treatment options

Developed by Samsung Bioepis and marketed by Sandoz, Pyzchiva is approved for all the same indications as Stelara, including:

  • Moderate-severe plaque psoriasis in adults and children aged 6 and above.
  • Active psoriatic arthritis in adults and children aged 6 and above.
  • Moderately to severely active Crohn’s disease in adults.
  • Moderately to severely active ulcerative colitis in adults.

Provisional Interchangeability

The FDA has given Pyzchiva the “provisional interchangeability” status, which means that it will be simpler and easier to use in the future.

Basically, pharmacists will be allowed to change a patient’s Stelara prescription to Pyzchiva without needing a new prescription from the doctor.

So, the entire process becomes much easier for both parties to handle. However, this switch can only happen after Wezlana, the first interchangeable biosimilar, has had its exclusive time on the market. 

Once this period ends, the FDA can completely approve the use of Pyzchiva instead of Stelara.


Impact on patients and the future

For several reasons, this approval of Pyzchiva is good news for people who are looking for an effective treatment for their chronic inflammatory conditions on a budget. 

As biosimilars like Pyzchiva are being approved by the FDA, companies will be encouraged to take the route of cheaper and more effective drug manufacturing.

In the end, such drugs will help healthcare budgets and insurance coverage, allowing more patients to access these life-changing medications. Pyzchiva will be launched in February 2025.


Other biosimilars approved by the FDA:

  • Eculizumab biosimilars:

This one targets a protein involved in a unique blood disorder called paroxysmal nocturnal hemoglobinuria (PNH).

Due to this, the immune system ends up attacking the body’s red blood cells, and Eculizumab biosimilars can help prevent this from happening.

Examples include Bkemv (eculizumab-aeeb) by Amgen, approved in May 2024.

  • Aflibercept biosimilars:

Such drugs are used for several cancers like colorectal cancer as well as wet age-related macular degeneration (AMD) which is a cause of vision loss in adults.

Examples include Opuviz and Yesafili, both approved in May 2024 [ref].

  • Adalimumab biosimilars:

This can treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and hidradenitis suppurativa (a chronic condition that causes painful lumps and abscesses).

Examples include Simlandi (adalimumab-ryvk) by Coherus, approved in February 2024, and Yuflyma by Pfizer, approved in May 2023.

  • Bevacizumab biosimilars:

These are used for chemotherapy for colorectal, lung, brain, and cervical cancers.

Avzivi by Coherus BioSciences, FDA-approved in December 2023, provides cheaper treatment options for these cancers.

  • Denosumab biosimilars:

These drugs prevent and treat osteoporosis, a condition that weakens bones and increases fracture risk, especially in postmenopausal women and men with low testosterone.

Jubbonti (denosumab-bbdz) by Samsung Bioepis and Wyost (denosumab-bbdz) by Amgen were approved in March 2024, offering cheaper alternatives for patients.

  • Tocilizumab biosimilars:

Lastly, this one treats rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Tyenne by Celltrion was approved in March 2024, and Tofidence by Samsung Bioepis in September 2023. It blocks IL-6, a protein involved in inflammation.

What do you think?

Written by Dr. Ahmed

I am Dr. Ahmed (MBBS; FCPS Medicine), an Internist and a practicing physician. I am in the medical field for over fifteen years working in one of the busiest hospitals and writing medical posts for over 5 years.

I love my family, my profession, my blog, nature, hiking, and simple life. Read more about me, my family, and my qualifications

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