Key Takeaways:
- Ustekinumab-kfce (Yesintek) gets approval from the FDA as a biosimilar to ustekinumab (Stelara) for the management of multiple inflammatory conditions.
- The biosimilar acts by targeting ulcerative colitis (UC), Crohn’s disease, plaque psoriasis, and psoriatic arthritis (PsA).
- According to the licensing agreement, this biosimilar will be commercially available by February 22, 2024.
- This approval is important and highlights the promising role of biosimilars in offering low-cost effective treatment alternatives.
On December 01, 2024, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd announced that the U.S. Food and Drug Administration (FDA) has given the green light to their new medicine Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara (ustekinumab).
What is Yesintek Approval For?
Yesintek is formulated as a monoclonal antibody. It helps manage several inflammatory complications. This newly approved medicine acts by targeting cytokines IL-12/23. These cytokines are important in regulating the immune system. The medicinal product gets approval to treat and manage:
- Psoriatic Arthritis (PsA)
- Crohn’s Disease
- Plaque Psoriasis
- Ulcerative Colitis (UC)
The licensing agreement clears that this biosimilar will be commercially in the market by February 22, 2024.
How Does it Work?
This therapeutic drug works by stopping specific immune responses to halt inflammation. It helps control T-cell activity and mediates the responses of the immune system. This mechanism relieves the symptoms related to these inflammatory complications.
Safety and Side Effects:
Yesintek is effective but also may cause some side effects. Common side effects include:
- Fever
- Cold-like symptoms
- Headache
- Fatigue
- Respiratory infections
- Abdominal pain
- Diarrhea
- Injection site reactions (redness or swelling)
Consult your healthcare professional (HCP) if you experience any side effects throughout the treatment.
The Increasing Role of Biosimilars:
This new medicine (Yesintek) is the 6th biosimilar of Stelara (ustekinumab-kfce) which gets approval by the US FDA. Below mentioned are some other recently approved biosimilars:
- Otulfi (ustekinumab-aauz)
- Imuldosa (ustekinumab-srlf)
- Selarsdi (ustekinumab-aekn)
- Wezlana (ustekinumab-auub)
- Pyzchiva (ustekinumab-ttwe)
Certain conducted clinical studies demonstrate that these important biosimilars are identical in safety, effectiveness, and tolerability to Stelara. This introduction provides patients with low-cost alternatives.
Why do Biosimilars Matter?
Biosimilars are worth it because they raise competition and decrease the cost of expensive therapies. At launch, these vital biosimilars can cost up to 50 percent less than the innovator’s medicinal product. As time progresses, competition can reduce the price even further.
Yesintek’s approval is an important step in developing advanced therapies like ustekinumab. With this approval, this medicine is readily accessible and affordable for patients across the planet. With some more biosimilars, more individuals can readily access life-saving medicines at the most reasonable cost.
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