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Teva, Alvotech Launch SELARSDI, Stelara Biosimilar

SELARSDI injection is approved for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech have 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.”

“The U.S. launch of SELARSDI is an important step for our partnership and reaffirms a joint commitment to providing more affordable treatment options for U.S. patients,” added Anil Okay, Chief Commercial Officer for Alvotech. “Alvotech’s fully integrated approach to development and manufacturing, coupled with our focus on biosimilars, enables us to continue expanding a portfolio of high-quality biologics and contribute meaningfully to lowering healthcare costs worldwide.”

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