FDA approves biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals

Alvotech and Teva Pharmaceuticals have achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of SIMLANDI (adalimumab-ryvk) injection. This approval positions SIMLANDI as an interchangeable biosimilar to Humira, a leading treatment for various arthritis and inflammatory conditions. The approval covers a wide range of conditions, including adult rheumatoid arthritis, juvenile idiopathic arthritis, and several others, marking a pivotal moment in the accessibility and affordability of treatment options in the United States.

SIMLANDI distinguishes itself as the first high-concentration, citrate-free biosimilar to Humira granted interchangeability status by the FDA. This unique designation allows SIMLANDI to be substituted at the pharmacy level without consulting the prescriber, akin to generic drug substitutions, providing a seamless transition for patients seeking alternative treatment options. This approval is particularly significant given that nearly 88 percent of U.S. prescriptions for adalimumab are for the high-concentration presentation.

FDA grants approval to biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals

The strategic partnership between Alvotech and Teva Pharmaceuticals, initiated in August 2020, underlines the collaborative effort to increase the availability and uptake of biosimilars in the U.S. market. With Alvotech handling development and manufacturing and Teva responsible for U.S. commercialization, the partnership leverages each company’s strengths to bring innovative treatment options to market. SIMLANDI’s approval is a testament to the partnership’s commitment to expanding access to affordable biologics.

The approval of SIMLANDI by the FDA is based on a comprehensive clinical development program, underscoring the biosimilar’s efficacy, safety, and immunogenicity. As the healthcare system faces increasing inflationary pressures, biosimilars like SIMLANDI offer a viable solution to reduce costs while maintaining high standards of patient care. This approval not only represents a significant advancement in treatment options but also signals a shift towards more sustainable healthcare practices.