Ahead of next year’s expected launch of biosimilars to reference product Stelara®, partners Alvotech and Teva have been given FDA approval for Selarsdi (ustekinumab-aekn), the second of at least five ustekinumab biosimilars awaiting an FDA decision.
Last year, the partners signed an agreement with Johnson & Johnson, allowing a launch of Selarsdi on February 21, 2025. The drug will be marketed in the US by Teva.
Interestingly, this ustekinumab biosimilar seems to have been approved initially with a “skinny label.” The interleukin 12/23 inhibitor is indicated for the treatment of moderate-to-severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Selarsdi is not approved for Stelara’s inflammatory bowel disease (IBD) indications (moderate-to-severe active Crohn’s disease and moderate-to-severe active ulcerative colitis), which represents a significant proportion of utilization for the reference product. In contrast, Amgen’s approval of Wezlana® did incorporate the IBD indications.
When asked to comment, an Alvotech spokesperson replied that the company does not yet have approval for the intravenous infusion administration (which is necessary for induction dosing in IBD), but does expect to have that approval and subsequently the approval for IBD indications at launch.
In a press release, Thomas Rainey, Senior Vice President, US Market Access at Teva stated, “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US.”
Alvotech’s CEO and Chairman, Robert Wessman, said, “Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs.”
In Other Biosimilar News: Tyenne Launches
On April 15, 2024, Fresenius Kabi announced that it had launched its tocilizumab biosimilar Tyenne®. As we previously reported, Fresenius Kabi received FDA approval in March for Tyenne in both the intravenous infusion and subcutaneous injection forms. However, only the intravenous infusion is being launched at present.
(Note: This post was updated to include Alvotech’s response on April 25, 2024)
