Teva and Alvotech Introduce Simlandi Injection in US Markets

Overview

Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. and Alvotech announced the availability of Simlandi (adalimumab-ryvk) injection in the US, as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.

Teva on Biosimialrs

• “We are proud to make Simlandi available in the US to patients and providers,” said Thomas Rainey, senior vice president, US market Access at Teva. 
• “Biosimilars create opportunities for cost savings across the healthcare system, and Simlandi’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the US market. We will be working with payors to ensure access to Simlandi, as well as the six other biosimilars we are committed to bringing to market by 2027.”

Simlandi: FDA Approval

• Simlandi is approved by the US Food and Drug Administration (FDA) as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4mL injection. 
• While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the US today, nearly 88 per cent of US prescriptions for adalimumab are for the high-concentration presentation.

Words from CCO: Alvotech

“It is a great pleasure to be able to offer US patients access to Simlandi, the only citrate-free, high-concentration interchangeable biosimilar to Humira. We look forward to increasing the availability of cost-effective quality biosimilars in the US, as they can be an important contributor to reduced inflationary pressure for healthcare providers and patients,” said Anil Okay, chief commercial officer of Alvotech.

About Partnership

• Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates in August 2020, and in July 2023, the collaboration was extended to include two additional biosimilars and new presentations of two previously partnered products. 
• Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the US, which leverages Teva’s experience and extensive sales and marketing infrastructure. 
• Simlandi is the first biosimilar launched under the strategic partnership, and in April 2024, the FDA approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and paediatric patients 6 years and older.

Humira is a registered trademark of AbbVie Biotechnology Ltd. Stelara is a registered trademark of Johnson & Johnson.

Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine.

About Alvotech

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!