Like its branded reference product, Selarsdi is a subcutaneous injection that can be used to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in pediatric and adult patients. Unlike Stelara, however, Selarsdi is not approved for Crohn’s disease and ulcerative colitis.
Tag Archive for: Stelara
Johnson & Johnson’s first quarter revenue missed Wall Street estimates on Tuesday with sales of its blockbuster psoriasis drug Stelara coming in lower than expected as the company prepares for its loss of exclusivity in the United States.
Alvotech said on Thursday it has reached settlement agreements with Johnson & Johnson for launching a biosimilar of the pharmaceutical giant’s blockbuster psoriasis drug Stelara in Japan, Canada, and Europe this year.
The company forecasted revenue growth of 5-6% for the next year, as it banks on strong demand for cancer treatments Darzalex and Carvykti and resilient sales of blockbuster drug Stelara.
The Department of Health and Human Services in a court filing last week said that the blockbuster treatment could be “deselected” from the drug price negotiation list, given the recent approval of Amgen’s Stelara biosimilar.
In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
Stelara, J&J’s top-selling anti-inflammatory drug, brought in sales of $2.86 billion in the quarter, above LSEG estimates of $2.61 billion.
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
J&J is heading into the remainder of 2023 with a new look and a revised outlook.
