- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Samsung Bioepis Initiates Phase 3 Ustekinumab Trial
Samsung Bioepis launches a potential pivotal trial for its SB17 ustekinumab biosimilar candidate.
Just days after Bio-Thera announced initiation of a phase 3 study of patients receiving a candidate ustekinumab biosimilar, Samsung Bioepis said that it, too, has begun a phase 3 clinical trial for its own biosimilar version of this agent.
The reference ustekinumab product is Stelara, which commands a $5 billion market among patients with autoimmune diseases. Samsung’s trial will evaluate SB17 in patients with moderate-to-severe plaque psoriasis in a randomized, double-blind, multicenter analysis.
In the United States, Stelara is indicated for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderate-to-severe Crohn disease, and moderate-to-severe ulcerative colitis. The drug was first approved in 2009 and potentially could see the end of US patent protection in 2023.
If SB17 is approved for plaque psoriasis, physicians in the United States could extrapolate its use for other indications of the reference product.
Samsung Bioepis said it aims to enroll 464 patients in the phase 3 trial and randomize them 1:1 to either SB17 or the reference product via subcutaneous injection. At week 28, all patients on Stelara will be randomized to continue on Stelara or transition to SB17. A final assessment will be performed at week 52. The study’s estimated primary completion date is June 2022.
For more about Bio-Thera’s ustekinumab biosimilar development program, click here.
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
