- In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference product Stelara® (ustekinumab) and has granted a provisional determination of interchangeability for SELARSDI
- SELARSDI is the second biosimilar to launch in the U.S. under the Teva and Alvotech strategic partnership, which includes nine products
- SELARSDI is approved 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
REYKJAVIK, Iceland and PARSIPPANY, NJ, USA I February 21, 2025 I Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today 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,” 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.”
SELARSDI is approved by the U.S. Food and Drug Administration (FDA) in several presentations, matching the approved presentations of the reference biologic Stelara (ustekinumab). The FDA has provisionally determined that all presentations of SELARSDI can be approved as interchangeable to Stelara® (ustekinumab) injection upon expiry of exclusivity on April 30, 2025, for the first interchangeable biosimilar. The four 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. 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®.1
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 the experience and extensive sales and marketing infrastructure from Teva. Two biosimilars developed under the partnership have been given U.S. FDA approval: most recently, SELARSDI in April 2024; and in February 2024, SIMLANDI® (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira®, which was launched in the U.S. in May 2024.
About SELARSDI™ (ustekinumab-aekn)
SELARSDI is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.2 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.
Use of Trademarks
Stelara® is a registered trademark of Johnson & Johnson. Humira® is a registered trademark of AbbVie Biotechnology Ltd. JAMTEKI™ is a trademark of JAMP Pharma Group. UZPRUVO® is a registered trademark of STADA and Alvotech.
SELARSDI INDICATIONS AND SAFETY INFORMATION
INDICATIONS
SELARSDI™ (ustekinumab-aekn) Injection, is a human interleukin-12 and -23 antagonist indicated for:
• the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
• the treatment of adult patients with moderately to severely active Crohn’s disease.
• the treatment of adult patients with moderately to severely active ulcerative colitis.
Please click here for full Prescribing Information for SELARSDI.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global pharmaceutical 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. If patients have a need, we’re already working to address it. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
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. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.
Sources
- Stelara® (ustekinumab) prescribing information. FDA product label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761044s013lbl.pdf. Accessed on February 3, 2025.
- SELARSDI™ (ustekinumab-aekn) injection [current prescribing information]. FDA product label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s000lbl.pdf. Accessed on February 3, 2025.
SOURCE: Teva Pharmaceutical Industries
Post Views: 621
- In October 2024, the U.S. Food and Drug Administration (FDA) approved SELARSDI™ for all indications matching the reference product Stelara® (ustekinumab) and has granted a provisional determination of interchangeability for SELARSDI
- SELARSDI is the second biosimilar to launch in the U.S. under the Teva and Alvotech strategic partnership, which includes nine products
- SELARSDI is approved 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
REYKJAVIK, Iceland and PARSIPPANY, NJ, USA I February 21, 2025 I Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today 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,” 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.”
SELARSDI is approved by the U.S. Food and Drug Administration (FDA) in several presentations, matching the approved presentations of the reference biologic Stelara (ustekinumab). The FDA has provisionally determined that all presentations of SELARSDI can be approved as interchangeable to Stelara® (ustekinumab) injection upon expiry of exclusivity on April 30, 2025, for the first interchangeable biosimilar. The four 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. 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®.1
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 the experience and extensive sales and marketing infrastructure from Teva. Two biosimilars developed under the partnership have been given U.S. FDA approval: most recently, SELARSDI in April 2024; and in February 2024, SIMLANDI® (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira®, which was launched in the U.S. in May 2024.
About SELARSDI™ (ustekinumab-aekn)
SELARSDI is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.2 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.
Use of Trademarks
Stelara® is a registered trademark of Johnson & Johnson. Humira® is a registered trademark of AbbVie Biotechnology Ltd. JAMTEKI™ is a trademark of JAMP Pharma Group. UZPRUVO® is a registered trademark of STADA and Alvotech.
SELARSDI INDICATIONS AND SAFETY INFORMATION
INDICATIONS
SELARSDI™ (ustekinumab-aekn) Injection, is a human interleukin-12 and -23 antagonist indicated for:
• the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
• the treatment of adult patients with moderately to severely active Crohn’s disease.
• the treatment of adult patients with moderately to severely active ulcerative colitis.
Please click here for full Prescribing Information for SELARSDI.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global pharmaceutical 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. If patients have a need, we’re already working to address it. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
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. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.
Sources
- Stelara® (ustekinumab) prescribing information. FDA product label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761044s013lbl.pdf. Accessed on February 3, 2025.
- SELARSDI™ (ustekinumab-aekn) injection [current prescribing information]. FDA product label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s000lbl.pdf. Accessed on February 3, 2025.
SOURCE: Teva Pharmaceutical Industries
Post Views: 621
