Teva and Alvotech Expand U.S. Biosimilar Portfolio with Approval for SELARSDI™
Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) have announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) as an interchangeable biosimilar to Stelara® (ustekinumab). The approval, effective April 30, 2025, covers all presentations of the reference product.
SELARSDI is now approved for all indications of the reference biologic, including the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged six and older, as well as adults with moderately to severely active Crohn’s disease and ulcerative colitis.
“The FDA’s confirmation of full interchangeability for SELARSDI is an important milestone for patients and providers seeking broader access to critical therapies,” said Thomas Rainey, Senior Vice President of U.S. Biosimilars at Teva. “With the launch of SELARSDI and EPYSQLI, along with a robust pipeline, Teva is well-positioned to lead in the evolving biosimilars space and fuel future growth.”
Anil Okay, Chief Commercial Officer at Alvotech, added, “Interchangeability with Stelara will make SELARSDI a more accessible and cost-effective treatment option for U.S. patients, helping to reduce overall healthcare costs. This approval underscores our commitment to delivering high-quality biosimilars through an integrated development and manufacturing approach.”
Approved Presentations of SELARSDI Include:
- 45 mg/0.5 mL and 90 mg/mL in single-dose prefilled syringes (subcutaneous injection)
- 45 mg/0.5 mL in a single-dose vial (subcutaneous injection)
- 130 mg/26 mL in a single-dose vial (intravenous infusion)
SELARSDI, like the reference product Stelara, is a human monoclonal antibody that targets the p40 subunit shared by interleukin (IL)-12 and IL-23—cytokines involved in various immune-mediated and inflammatory diseases. Alvotech developed SELARSDI using Sp2/0 cells and a continuous perfusion manufacturing process, the same host cell line and method used in Stelara production.
The approval of SELARSDI follows the FDA’s February 2024 approval of SIMLANDI® (adalimumab-ryvk), another interchangeable biosimilar developed under the Teva–Alvotech partnership. SIMLANDI, the first high-concentration, citrate-free biosimilar to Humira® (adalimumab), launched in the U.S. in May 2024.
The strategic partnership between Teva and Alvotech began in 2020 for the commercialization of five biosimilar candidates in the U.S. It was expanded in 2023 to include two more biosimilars and new presentations of previously partnered products. Under the agreement, Alvotech oversees development and manufacturing, while Teva manages U.S. commercialization.
Three additional Biologics License Applications (BLAs) from Alvotech are currently under FDA review:
- AVT05, a proposed biosimilar to Simponi® and Simponi Aria® (golimumab)
- AVT06, a proposed biosimilar to Eylea® (aflibercept)
BsUFA goal dates for these candidates are anticipated in the fourth quarter of 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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners.
