In a significant step for psoriasis treatment, Alvotech and the U.S division of Teva Pharmaceutical Industries Ltd recently received a nod of approval from the U.S. Food and Drug Administration (FDA) for their innovative drug, SELARSDI (ustekinumab-aekn). The FDA approval acknowledges the drug as a biosimilar to Stelara (ustekinumab), widely recognized for its effectiveness in managing moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged 6 years and above.
This development is the outcome of the strategic partnership inked between Teva, a globally reputed pharmaceutical company, and Alvotech, an international biopharmaceutical company focused on the development and manufacture of high-quality biosimilars for global markets. According to the agreement, Teva will bear sole responsibility for the exclusive commercialization of SELARSDI within the United States.
The approval of SELARSDI by the FDA marks it as a worthy competitor of Stelara, offering patients an approved alternative for managing their skin condition. Injection-based and intended for subcutaneous use, SELARSDI aims to provide a viable treatment option for the millions of American adults and children battling moderate to severe plaque psoriasis and active psoriatic arthritis.
This development represents a significant stride forward in the field of biosimilars and reinforces the commitment of Alvotech and Teva towards developing efficient and affordable healthcare solutions. With FDA’s stamp of approval, SELARSDI stands to offer new hope for those affected by psoriasis, offering another pathway towards disease management and improved quality of life.
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