Selarsdi (Ustekinumab Biosimilar) Launched in USA
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Alvotech announced the availability of Selarsdi (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis.
This is the second biosimilar now available in the U.S. market under the Teva and Alvotech strategic partnership. The FDA has provisionally determined that Selarsdi will be interchangeable with the reference biologic Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.
“Biosimilars like Selarsdi create opportunities for cost savings across the healthcare system, and we are proud to be able to introduce our second biosimilar treatment option in partnership with Alvotech to U.S. patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “The U.S. availability of Selarsdi reinforces Teva’s overall strategy to identify strategic business partners to develop and manufacture biosimilars while leveraging Teva’s commercial presence and experience to bring this and other products to the U.S. market.”
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