Biosimilar boom set to expand treatment landscape for IBD, inflammatory diseases in 2025
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The expansion of safe and effective FDA-approved biosimilars for inflammatory bowel disease set to launch in early 2025 may improve access to care, with the potential to reduce health care costs and revolutionize the treatment landscape.
Within the last year, the FDA has approved several notable agents including the sixth biosimilar for Stelara (ustekinumab, Janssen) and the third interchangeable biosimilar for Humira (adalimumab, AbbVie). The agency also cleared a citrate-free, high-concentration formulation of the interchangeable adalimumab biosimilar Cyltezo (adalimumab-adbm, Boehringer Ingelheim) intended for the treatment of IBD, as well six other inflammatory conditions across rheumatology and dermatology.
“We are in a time where biosimilars for Crohn’s disease and ulcerative colitis are becoming the ‘norm,’” Miguel Regueiro, MD, professor of medicine and chief of the Digestive Disease Institute at Cleveland Clinic, told Healio. “With the advent of biosimilars, this should improve access for patients needing these medications and expand options for treatment.”
Looking into 2025, Regueiro added that it “remains to be seen” whether the uptake of biosimilars will result in a cost reduction for patients.
Healio continues to closely monitor FDA approvals to provide up-to-date guidance on biosimilar uptake for IBD and other inflammatory diseases. In case you missed it, Healio recaps 2024 approvals in gastroenterology, rheumatology and dermatology below.
FDA expands approval of Stelara biosimilar Selarsdi to include UC, Crohn’s disease
The FDA approved the Stelara biosimilar, Selarsdi, as a 130 mg/26 mL single-dose IV infusion for adult patients with Crohn’s disease and ulcerative colitis, Alvotech and Teva Pharmaceuticals announced in a press release.
The agency had previously approved 45 mg/0.5 mL and 90 mg/mL subcutaneous formulations of Selarsdi (ustekinumab-aekn) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. With this expanded approval, Selarsdi further reinforced its position as a contender with other Stelara biosimilars expected to flood the market in early 2025. Read more.
FDA approves Yesintek, sixth Stelara biosimilar; launch slated for February
The FDA has approved the Stelara biosimilar Yesintek for indications matching the reference product, with a commercial launch date expected for early 2025, according to a press release from Biocon Biologics.
Yesintek (ustekinumab-kfce, Biocon) is approved for psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis. It is the sixth approved biosimilar for Stelara. Read more.
Imuldosa snags FDA approval as fifth Stelara biosimilar in mounting market logjam
The FDA has approved the Stelara biosimilar, Imuldosa, for Crohn’s disease, ulcerative colitis and all other indications of the reference product, and the latest addition to the Stelara biosimilar bottleneck set to release in 2025.
Imuldosa (ustekinumab-srlf; Intas Pharmaceuticals, Accord Biopharma) is now the fifth FDA-approved biosimilar for Stelara to enter the chronic inflammatory diseases market following the recent approval of Otulfi (ustekinumab-aauz; Fresenius Kabi, Formycon AG) in September. However, to date, none of these biosimilars have been launched in the U.S. market as Stelara remains patent-protected until early 2025. Read more.
FDA approves Otulfi as fourth Stelara biosimilar for chronic inflammatory diseases
The FDA has approved subcutaneous and IV formulations of the Stelara biosimilar Otulfi for Crohn’s disease, ulcerative colitis and all other indications approved for the reference product, according to a press release from Fresenius Kabi.
Not only is Otulfi Fresenius Kabi’s fourth biosimilar to launch in the U.S. market, but also the fourth FDA-approved biosimilar for Stelara after the approval of interchangeable biosimilar Pyzchiva (ustekinumab-ttwe; Samsung Bioepis, Sandoz) in July. Following a patent settlement between Fresenius Kabi, their partner Formycon and Johnson & Johnson, this newest biosimilar is set to enter the U.S market by February 2025, according to the release. Read more.
FDA approves biosimilar Pyzchiva for all approved Stelara indications
The FDA has approved the Stelara biosimilar Pyzchiva for psoriatic arthritis, Crohn’s disease and all other indications approved for the reference medicine, according to a press release from Sandoz.
Pyzchiva is slated to debut on the U.S. marketplace in February, according to the release. The Stelara biosimilar, which has received interchangeable designation, was developed by Samsung Bioepis and licensed for marketing by Sandoz. Read more.
Simlandi launches in US as third interchangeable Humira biosimilar
Simlandi injection, an interchangeable biosimilar to Humira, is now available in the U.S. for the treatment of psoriatic arthritis, plaque psoriasis and other conditions, Teva Pharmaceuticals and Alvotech announced in a press release.
As Healio previously reported, Simlandi (adalimumab-ryvk) was approved in February as the first interchangeable, citrate-free Humira biosimilar to be available in a high-concentration formulation for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis as well as Crohn’s disease and juvenile idiopathic arthritis. Read more.
FDA approves high-concentration, citrate-free form of interchangeable biosimilar Cyltezo
The FDA has approved a citrate-free, high-concentration formulation of the interchangeable adalimumab biosimilar Cyltezo to treat multiple chronic inflammatory diseases, according to the manufacturer.
As with the low-concentration (50 mg/mL) version of Cyltezo, the high-concentration formulation is approved for Crohn’s disease and ulcerative colitis, as well as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile arthritis, hidradenitis suppurativa and chronic plaque psoriasis. Read more.
FDA approves Simlandi as third interchangeable Humira biosimilar
The FDA has approved Simlandi as the third interchangeable biosimilar to Humira following a rejection in April 2023 stemming from issues at the developer’s manufacturing facility.
Simlandi is the first interchangeable, citrate-free Humira biosimilar to be available in a high-concentration formulation, according to a joint statement from Alvotech, the drug’s manufacturer, and Teva Pharmaceutical Industries, its biosimilar commercialization partner in the United States. Read more.
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