Teva Pharmaceuticals and Alvotech Announce the Launch of SELARSDI™, a Biosimilar for the Treatment of Autoimmune Conditions in the U.S.
On February 21, 2025, Teva Pharmaceuticals, a leading global pharmaceutical company, and Alvotech, a premier clinical-stage biotechnology company, announced the availability of SELARSDI™ (ustekinumab-aekn) injection in the United States. This biosimilar is an alternative to Stelara® (ustekinumab), a reference biologic used for the treatment of various autoimmune conditions, including psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis.
FDA Provisional Interchangeability Determination
The Food and Drug Administration (FDA) has provisionally determined that SELARSDI™ will be interchangeable with Stelara® following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. Interchangeability means that a pharmacist can substitute SELARSDI™ for Stelara® without the intervention of the healthcare provider, provided the prescribing healthcare provider has documented that the patient may be safely switched.
Second Biosimilar under Teva and Alvotech Strategic Partnership
This collaboration marks the second biosimilar to be introduced in the U.S. market under the Teva and Alvotech strategic partnership. The first biosimilar, Cyltezo™ (adalimumab-adbm), was approved in 2023 for the treatment of several inflammatory conditions.
Impact on Patients
For patients diagnosed with the aforementioned autoimmune conditions, the availability of SELARSDI™ as an interchangeable biosimilar provides several benefits:
- Cost savings: Biosimilars are typically priced lower than their reference biologics, potentially resulting in cost savings for patients and healthcare systems.
- Increased access: The introduction of biosimilars can lead to increased competition in the market, potentially resulting in more treatment options for patients and improved access to care.
- Reduced administrative burden: The ability to substitute biosimilars for their reference biologics without the intervention of the healthcare provider can lead to reduced administrative burden and streamlined care delivery.
Impact on the World
The introduction of SELARSDI™ in the U.S. market is not only significant for patients in the United States but also for the global community:
- Cost savings: The availability of affordable biosimilars can lead to substantial cost savings for healthcare systems and patients in other countries as well.
- Improved access to treatment: The introduction of biosimilars can help address treatment gaps in countries with limited resources and limited access to biologic therapies.
- Encouragement of innovation: The approval of interchangeable biosimilars can encourage further investment in biosimilar development, leading to the introduction of new, cost-effective treatment options for various conditions.
Conclusion
The announcement of the availability of SELARSDI™, an interchangeable biosimilar to Stelara®, marks an important milestone in the collaboration between Teva Pharmaceuticals and Alvotech. This development not only benefits patients in the United States by providing a cost-effective and convenient treatment option but also has the potential to create a ripple effect, leading to cost savings, increased access, and improved patient care on a global scale.
As we continue to navigate the complex world of healthcare and biologic therapies, the introduction of interchangeable biosimilars represents a significant step forward in ensuring affordable, accessible, and innovative care for patients worldwide.
