FDA Approves Stelara Biosimilar Imuldosa - Clinical Advisor
4 days ago · News release. Accord BioPharma. October 15, 2024. ... Accord BioPharma, Inc. announces US FDA acceptance of Biologics License Application for proposed Stelara ® biosimilar DMB-3115. News release ...
FDA Approves Stelara Biosimilar Imuldosa - MPR
5 days ago · October 15, 2024. The product is expected to be available in the first half of 2025. The Food and Drug Administration (FDA) has approved Imuldosa ™ (ustekinumab-srlf), a biosimilar to Stelara ...
FDA Approves Imuldosa, a Biosimilar to Stelara
Oct 11, 2024 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, according to Johnson & Johnson's annual financial report.It’s also 1 of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.
Imuldosa snags FDA approval as fifth Stelara biosimilar in ... - Healio
Oct 14, 2024 · 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 ...
Stelara patent deal puts J&J back on path to $57 billion 2025 …
Jun 5, 2023 · Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022. Its patents begin to expire this year, opening the door to a cheaper biosimilar...
FDA approves Amgen's interchangeable biosimilar of J&J's Stelara
Nov 1, 2023 · The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. But don’t hold your breath waiting for the California biotech to launch its new product.
FDA Approves Interchangeable Biosimilar for Multiple …
Nov 2, 2023 · Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana,...
New STELARA® (ustekinumab) Long-Term Data Support its …
Mar 4, 2023 · SPRING HOUSE, PENNSYLVANIA, March 4, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final pooled long-term safety results for STELARA ® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative ...
Teva Pharmaceutical Industries Ltd. - Alvotech and Teva Announce …
Apr 16, 2024 · Sales of the reference product Stelara in the U.S. were nearly $7 billion in 2023. 1 The availability of a Stelara biosimilar will create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients.
STELARA® (ustekinumab) Demonstrated Sustained Symptomatic …
Oct 10, 2022 · SPRING HOUSE, PENNSYLVANIA, October 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating efficacy and safety of STELARA ® (ustekinumab) through four years of treatment in adult patients with moderately to severely …