- The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025
- SELARSDI is approved for all indications matching the reference product
- SELARSDI is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older, and the treatment of adult patients with moderately to severely active Crohn’s disease and ulcerative colitis
PARSIPPANY, N.J. & REYKJAVÍK, Iceland, May 05, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). As of April 30, 2025, SELARSDI is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis.
"The FDA’s confirmation of full interchangeability for SELARSDI is an important development for patients and providers seeking to expand access to this important treatment," said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. "Teva’s recent launch of two biosimilars – SELARSDI and EPYSQLI – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy."
“Interchangeability of SELARSDI with Stelara will further enable increased access for U.S. patients to more affordable treatment options and contribute to lowering healthcare costs, which is an important part of our mission as a leading developer and manufacturer of biosimilars globally,” said Anil Okay, Chief Commercial Officer for Alvotech. “With two important biosimilars on the U.S. market and Biologics License Applications for three new biosimilar candidates under FDA review, Alvotech continues to rapidly expand its portfolio of high-quality biologics based on a fully integrated approach to development and manufacturing, coupled with a unique focus on biosimilars.”
Approved presentations of SELARSDI are 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.
Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis[1]. Alvotech developed and produces SELARSDI using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara®.
In August 2020, Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five Alvotech biosimilar product candidates, and in July 2023, the partnership was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech manages development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., leveraging its experience and extensive sales and marketing infrastructure.
Two biosimilars developed under the Teva - Alvotech partnership have been granted FDA approval with interchangeability, including SELARSDI. In February 2024, the FDA approved SIMLANDI® (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira® (adaliumumab),which was launched in the U.S. in May 2024.
Biologics License Applications (BLAs) for three additional biosimilar candidates developed by Alvotech in partnership with Teva have been accepted for review by the FDA: AVT05, a proposed biosimilar for Simponi® (golimumab) and Simponi Aria® (golimumab), and AVT06, a proposed biosimilar for Eylea® (aflibercept). Biosimilar User Fee Act (BsUFA) goal dates for approval for these BLAs are in Q4 2025.
About SELARSDI™ (ustekinumab-aekn)
SELARSDI is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). The biosimilar has been launched in Canada as JAMTEKI™, in Europe as UZPRUVO® and in Japan as USTEKINUMAB BS (F). It has been approved in the U.S. as SELARSDI. Applications are also under review in multiple countries globally.
About SIMLANDI™ (adalimumab-rvyk)
SIMLANDI is a monoclonal antibody and a biosimilar to Humira® (adalimumab). It has been approved as a biosimilar to Humira® in over 50 countries globally, including the U.S. It is currently marketed in the U.S. as SIMLANDI and under private label (adalimumab-ryvk), in Europe as HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALICIP. Applications are also under review in multiple countries globally.
About AVT05
AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in the pathophysiology of several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About AVT06
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg dose, which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [3]. AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Use of Trademarks
Stelara®, Simponi® and Simponi Aria ® are registered trademarks of Johnson & Johnson. Humira® is a registered trademark of AbbVie Biotechnology Ltd. Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc. JAMTEKI™ is a trademark of JAMP Pharma Group. UZPRUVO® and HUKYNDRA® are registered trademarks of STADA and Alvotech. ADALICIP is a registered trademark of Cipla Australia.
