Selardsi Launches in the US Market

Selarsdi (ustekinumab-aekn) an injection for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis that is also a biosimilar to Stelara (ustekinumab), is officially available in the United States.1 This represents under second biosimilar available in the US market under the Teva and Alvotech strategic partnership.

The FDA made the ruling that Selarsdi would be interchangeable with the reference biologic Stelara, once exclusivity for the first interchangeable biosimilar expires on April 30. The organization had approved the injection for all indications matching its reference product in October 2024.

“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 US patients and providers,” said Thomas Rainey, senior vice president, US biosimilars at Teva. “The US 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 US market.”

Selarsdi is approved by the FDA in several presentations, including 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, 45 mg/0.5 mL in a single-dose vial for subcutaneous injection, and 130 mg/26 mL in a single-dose vial for intravenous infusion.

“The US launch of Selarsdi is an important step for our partnership and reaffirms a joint commitment to providing more affordable treatment options for US patients,” said 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 world-wide.”

Teva and Alvotech’s relationship dates back to August 2020, when the parties entered into a strategic partnership for the commercialization of five Alvotech biosimilar product candidates. That collaborative effort was furthered in July 2023, when the partnership was extended to feature two more biosimilars, along with new presentations of two previously partnered products.

Alvotech handles the development and manufacturing, while Teva is in charge of the US commercialization efforts. In April of last year, the companies struck a deal in which Alvotech would produce its high-concentration, interchangeable biosimilar to Humira—also known as adalimumab—for Quallent Pharmaceuticals, a private label pharma distributor. Teva is who’s handling the commercialization.2

“We are pleased to be working with Alvotech to bring adalimumab-ryvk to more patients. Our intent is to offer a copay assistance program, which will provide eligible patients access,” said John Caufield, president of Quallent Pharmaceuticals Health, LLC. “Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal.”

References

1. Teva and Alvotech Announce Selarsdi (ustekinumab-aekn) Injection Now Available in the U.S. Alvotech. February 21, 2025. Accessed February 24, 2025. https://investors.alvotech.com/news-releases/news-release-details/teva-and-alvotech-announce-selarsditm-ustekinumab-aekn-injection

2. Saraceno N. Teva and Alvotech Further Strengthen Their Relationship, Reach Biosimilar Commercialization Deal. Alvotech. May 3, 2024. Accessed February 24, 2025. https://www.pharmaceuticalcommerce.com/view/teva-and-alvotech-further-strengthen-their-relationship-reach-biosimilar-commercialization-deal