Teva Pharmaceuticals and Alvotech Introduce New Biosimilar SELARSDI™ in the U.S. Market
In an exciting development for the biopharmaceutical industry, Teva Pharmaceuticals, a prominent affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) have recently announced the availability of SELARSDI™ (ustekinumab-aekn) injection in the United States. This biosimilar is an alternative to Stelara® (ustekinumab), which is used for treating various inflammatory conditions, including psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis.
A Strategic Partnership Yields Success
This marks the second biosimilar to be introduced in the U.S. market under the Teva and Alvotech strategic partnership. The Food and Drug Administration (FDA) has provisionally determined that SELARSDI will be interchangeable with the reference biologic, Stelara®. This determination follows the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.
Impact on Patients
For individuals diagnosed with these inflammatory conditions, the availability of SELARSDI as a biosimilar to Stelara® could bring about several benefits. Biosimilars are typically priced lower than their reference biologics, which could lead to cost savings for patients and healthcare systems. Moreover, having multiple treatment options increases the competitive landscape, potentially driving innovation and improving patient access to effective therapies.
Global Implications
The introduction of SELARSDI in the U.S. market is also significant on a global scale. The United States is just the beginning of this biosimilar’s journey. As Teva and Alvotech continue to collaborate, they will work towards gaining regulatory approvals in other countries. This could lead to increased access to affordable treatments for patients worldwide, particularly in regions where the cost of biologic medications remains high.
Conclusion
The launch of SELARSDI, a biosimilar to Stelara®, marks an important milestone in the partnership between Teva Pharmaceuticals and Alvotech. With the FDA’s provisional interchangeability determination, patients in the United States now have an affordable alternative to treat various inflammatory conditions. Furthermore, the global implications of this collaboration could lead to increased access to affordable treatments for patients worldwide. As the biosimilar landscape continues to evolve, we can expect more innovations and advancements that will improve patient care and affordability.
- Teva Pharmaceuticals and Alvotech announce the availability of SELARSDI™ in the U.S. market as a biosimilar to Stelara®.
- SELARSDI is used for treating psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis.
- This is the second biosimilar under the Teva and Alvotech strategic partnership to be introduced in the U.S. market.
- The 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.
- The availability of SELARSDI could lead to cost savings for patients and healthcare systems and increased competition, driving innovation and improving patient access to effective therapies.
- The introduction of SELARSDI in the U.S. market is just the beginning of its journey as Teva and Alvotech work towards gaining regulatory approvals in other countries, potentially leading to increased access to affordable treatments worldwide.
