Monday, July 15, 2024

Multiple Inflammatory Conditions Treated with FDA Approval of Third Ustekinumab Biosimilar

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Multiple inflammatory conditions can now be treated with ustekinumab-ttwe (Pyzchiva), a biosimilar to ustekinumab (Stelara), following its approval by the US Food and Drug Administration (FDA). This approval marks the addition of another biosimilar to the list of available treatments for conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Additionally, the FDA has “provisionally determined” that Pyzchiva would be interchangeable with the reference product, Stelara. However, this designation will not take effect until the interchangeability exclusivity period for the first approved biosimilar, ustekinumab-auub (Wezlana), expires. This provisional determination means that, depending on state law, pharmacists could substitute the biosimilar for the reference product without needing to consult the prescribing clinician. The exact date when ustekinumab-auub’s interchangeability exclusivity ends is currently unclear.

Ustekinumab-ttwe Approved for Multiple Inflammatory Conditions Including Plaque Psoriasis, PsA, and Crohn’s Disease

Indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy, ustekinumab-ttwe is also approved for active psoriatic arthritis (PsA) in adults, and for moderately to severely active Crohn’s disease or ulcerative colitis in both adults and pediatric patients aged 6 years or older.

The medication is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vials. These various administration methods provide flexibility in treatment, catering to the different needs and conditions of patients.

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi). The introduction of these biosimilars is part of a broader strategy to increase access to critical medications and provide more cost-effective treatment options for patients with chronic inflammatory conditions.

Ustekinumab-ttwe is expected to launch in February 2025, “in accordance with the settlement and license agreement with Janssen Biotech,” which manufactures the reference product, Stelara. The other approved ustekinumab biosimilars will launch within a similar timeframe, providing multiple options for clinicians and patients looking for alternatives to the reference product.

Multiple Inflammatory

FDA Approval of Ustekinumab-ttwe Marks Significant Progress in Treating Multiple Inflammatory Conditions

The recent FDA approval of ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) represents a significant development in the treatment of multiple inflammatory conditions. Pyzchiva joins a growing list of biosimilars designed to provide effective treatment for conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. These conditions often require long-term management and can significantly impact the quality of life of those affected.

Biosimilars like Pyzchiva offer a critical advantage by providing more affordable treatment options while maintaining the same efficacy and safety profile as the original biologic drugs. This can potentially reduce the financial burden on patients and healthcare systems, making high-quality care more accessible.

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The provisional determination of Pyzchiva’s interchangeability with Stelara is a notable aspect of this approval. Once the interchangeability exclusivity period for ustekinumab-auub (Wezlana) ends, pharmacists will be able to substitute Pyzchiva for Stelara without needing to involve the prescribing clinician, depending on state laws. This can streamline the treatment process and enhance patient access to necessary medications.

The diverse administration methods for ustekinumab-ttwe, including subcutaneous injections and intravenous infusions, offer flexibility for both patients and healthcare providers. This flexibility is crucial for managing chronic conditions that require ongoing treatment, as it allows for adjustments based on patient needs and preferences.

Samsung Bioepis, the developer of Pyzchiva, has partnered with Sandoz to commercialize the biosimilar in the United States. The collaboration between these companies is expected to enhance the availability and distribution of the medication, ensuring that it reaches patients who need it. The planned launch of Pyzchiva in February 2025, alongside other approved ustekinumab biosimilars, marks a significant step forward in expanding treatment options for inflammatory conditions.

In conclusion, the FDA’s approval of ustekinumab-ttwe (Pyzchiva) underscores the importance of biosimilars in modern healthcare. By providing effective and affordable alternatives to established biologic treatments, biosimilars like Pyzchiva can improve patient outcomes and increase access to essential medications. As the landscape of inflammatory disease treatment continues to evolve, the introduction of new biosimilars will play a crucial role in meeting the needs of patients and healthcare providers alike.


Resource: Sandoz, July 01, 2024

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