Wezlana (ustekinumab-auub) / Amgen - LARVOL DELTA

Guselkumab (Tremfya) for ulcerative colitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Unlocking hope: The future of ustekinumab biosimilars in Crohn's disease treatment. (PubMed, United European Gastroenterol J) - "While biosimilars of ustekinumab promise cost savings in treating moderate-to-severe CD, it is not yet known whether their availability will change the treatment algorithm in CD. This review focuses on the available data on ustekinumab biosimilars, focusing on their pros and cons for their forthcoming role in treating moderate to severe CD."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A

Assessing Functional Similarity of Biosimilar ABP 654 and Ustekinumab in Samples from Patients with Crohn's Disease. (PubMed, J Inflamm Res) - "These studies demonstrated similar inhibition of IL-23 and IL-12 function by ABP 654 and ustekinumab RP in both healthy and CD PBMCs. Overall, these assays support the conclusion that ABP 654 and ustekinumab RP are functionally similar, thereby contributing to the TOE supporting a demonstration of biosimilarity."

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease • IFNG • IL12A • IL17A • IL23A • STAT3 • STAT4

Efficacy and safety of the ustekinumab biosimilar ABP 654 in patients with moderate-to-severe plaque psoriasis: a randomized, double-blinded, active-controlled, comparative clinical study over 52 weeks. (PubMed, Br J Dermatol) - P3 | "These results indicate that ABP 654 and ustekinumab RP are clinically similar in efficacy, safety, and immunogenicity in patients with moderate-to-severe plaque psoriasis. Further, a single transition from ustekinumab RP to ABP 654 at week 28 had no impact on the efficacy, safety, or immunogenicity results for the remainder of the 52-week study, supporting a conclusion of no clinically meaningful differences between ABP 654 and ustekinumab RP."

Clinical • Journal • Dermatology • Immunology • Psoriasis

PHARMACOKINETIC COMPARABILITY OF ABP 654 ADMINISTERED EITHER VIA PREFILLED SYRINGE OR AUTOINJECTOR IN HEALTHY ADULT SUBJECTS: RESULTS FROM A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY (UEGW 2024) - "PK comparability was established between the PFS and AI groups. Both treatments were safe and well-tolerated. Overall, the results support conclusions of PK comparability and similar safety and immunogenicity profiles between ABP 654 administered via PFS and AI."

Clinical • PK/PD data • Immunology • Inflammatory Bowel Disease

In brief: Wezlana - an ustekinumab biosimilar interchangeable with Stelara. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Australia’s PBAC Recommends Three Biosimilars for Reimbursement (Pearce IP) - "Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting. The following biosimilars have been recommended for listing on the Pharmaceutical Benefits Scheme (PBS): Amgen’s Wezlana (ustekinumab); and Celltrion’s Yuflyma (adalimumab)...In addition, the following biopharmaceuticals have been recommended for first time listing on the PBS:...and Saphnelo (anifrolumab) for the treatment of patients with severe systemic lupus erythematosus with high disease activity despite standard of care; UCB’s Bimzelx (bimekizumab) for the treatment of severe psoriatic arthritis; new forms of Janssen-Cilag’s Stelara (ustekinumab), as 45 mg and 90 mg pre-filled syringe (PFS) and pre-filled pen (PFP)."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Systemic Lupus Erythematosus • Ulcerative Colitis

WEZLANA (USTEKINUMAB), A BIOSIMILAR TO STELARA, NOW AVAILABLE IN CANADA FOR CERTAIN CHRONIC INFLAMMATORY DISEASES (Canada Newswire) - "Amgen Canada...announced that WEZLANA (ustekinumab injection) and WEZLANA I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to STELARA, is now available in Canada. WEZLANA is the first biosimilar to STELARA to be approved by Health Canada for all indications. WEZLANA is indicated for adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis....Health Canada approval was based on a robust comprehensive data package, which found no clinically meaningful differences in efficacy, safety and immunogenicity between WEZLANA and STELARA. WEZLANA is available as a subcutaneous injection, 45 mg/0.5ml and 90 mg/ml and as an intravenous solution, 130 mg/26mL (5mg/mL)."

Biosimilar launch • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Pharmacokinetics and immunogenicity of the ustekinumab biosimilar candidate ABP 654 in patients with moderate-to-severe plaque psoriasis (ECCO-IBD 2024) - "While the percentages of binding and neutralising ADAs were numerically lower for the ABP 654 group compared with the ustekinumab RP group through Week 28 (and in patients who received dose intensification), the available clinical efficacy, safety, and PK data suggest that these differences were not clinically impactful. Overall, the results support a conclusion of no clinically meaningful differences between ABP 654 and ustekinumab RP."

Clinical • PK/PD data • Immunology • Inflammatory Bowel Disease

CareFirst Files Lawsuit Against J&J Over Delay Tactics for Stelara Biosimilars (AJMC) - "In approximately 1 year, Wezlana, the first ustekinumab (Stelara) biosimilar will launch in the United States, which represents more than a year delay from the time the biosimilar was approved. CareFirst BlueCross BlueShield, based in Maryland, has filed a lawsuit in the US District Court for the Eastern District of Virginia against Johnson & Johnson (J&J) for delaying the entry of biosimilar competition to Stelara....The lawsuit alleges J&J defrauded the US Patent and Trademark Office by filing claims to gain an exclusive patent for ulcerative colitis, which was used to delay companies from launching biosimilar versions of Stelara."

Corporate lawsuit • Atopic Dermatitis • Cardiovascular • Crohn's disease • Graft versus Host Disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product. (PubMed, Drugs R D) - "Based on a comprehensive similarity assessment, ABP 654 was found to be similar to ustekinumab RP, notwithstanding minor physicochemical differences that are not expected to have a clinically meaningful effect on safety or efficacy."

Journal • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases (FDA) - "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, like Stelara, is approved to treat the following indications: Adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis."

BLA • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double-blind Study in Healthy Subjects. (PubMed, Clin Pharmacol Drug Dev) - "Adverse events were similar between treatment groups and consistent with the safety profile of ustekinumab RP. Results indicate that ABP 654, ustekinumab US and ustekinumab EU share similar PK and safety profiles."

Clinical • Journal • PK/PD data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A

Amgen, J&J Settle Patent Dispute Over Stelara Biosimilar (BioSpace) - "Tuesday, Johnson & Johnson and Amgen reached a settlement in their patent dispute over the latter’s biosimilar candidate to J&J’s blockbuster antibody Stelara (ustekinumab), according to a Delaware court filing reported by Reuters. The exact terms of the settlement remain 'confidential' at this time..."

Corporate lawsuit • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Efficacy and Safety of the Biosimilar Candidate ABP 654 in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results from a Phase 3, Multicenter, Randomized, Double-blinded Study (EADV-Sp 2023) - "While the incidence of binding and neutralizing ADAs was numerically lower for the ABP 654 group compared with the ustekinumab RP group through Wk 28 (Table 1), clinical efficacy, safety, and PK data suggest that these observed differences are not clinically impactful. Conclusion Overall, the results indicate that there are no clinically meaningful differences in efficacy, safety, and immunogenicity between ABP 654 and ustekinumab RP."

Clinical • P3 data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A

A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=494 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Study Finds Ustekinumab and Vedolizumab Equally Persistent for Crohn’s After Anti-TNFs - "'As we've heard a lot over the last decade, anti-[tumor necrosis factor (TNF)] medications are really good medications for patients with Crohn's disease, often as a first-line medical therapy. But for a number of patients, anti-TNFs either don't work or they lose response over time. Fortunately, we have a growing number of tools in our toolbox,' said Michael D. Kappelman...'All of those other outcomes seem to slightly favor ustekinumab over vedolizumab,' Dr. Kappelman said."

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Serious Infection Risk in Pediatric Psoriasis with Ustekinumab, Etanercept, or Methotrexate (RheumNow) - "Etanercept was FDA approved for use in pediatric psoriasis (PsO) in 2016 and ustekinumab was similarly approved in 2020. This comparative analysis looks at the risk of serious infections (SIE) requiring hospitalization in pediatric PSO patients treated with ustekinumab, etanercept, or methotrexate prior to 2016....Pediatric psoriasis treated with immunomodulating agents infrequently causes serious infections, with little difference between etanercept, ustekinumab or MTX."

Online posting

Hope for Biologic Treatment of Hidradenitis Suppurativa (RheumNow) - "A meta-analysis of trials using biologics [adalimumab (ADA), ustekinumab (UST) and secukinumab (SEC)] in the the management of hidradenitis suppurativa (HS) suggests promising results, but more controlled, rigorous studies are needed....Ribero et a: retrospective study of 31 HS patients treated with SEC - the HiSCR was achieved by 41% of patients at week 28. No adverse events."

Online posting

IL-23 vs IL-17 Inhibitors: Why and When? (DermatologyTimes) - "April Armstrong...discuss the benefits of each inhibitor and the specific incidences of when to use them at Winter Clinical Hawaii....The 4 IL-23 inhibitors are known for their robust and long-lasting skin efficacy, there are very few injections per year, and each inhibitor has an overall good safety profile. Additionally, guselkumab, risankizumab, and ustekinumab have shown positive efficacy in the treatment of psoriatic arthritis."

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IL-17 Inhibitors for the Treatment of Plaque Psoriasis - Episode 4: Role of IL-17 Inhibitor Durability in Plaque Psoriasis - "Mark G. Lebwohl, MD, and Alice B. Gottlieb, MD, PhD, discuss the durability of IL-17 inhibitors in managing plaque psoriasis....Alice B. Gottlieb, MD, PhD: The simple answer to that question is yes. Is it the first thing that comes to mind? Probably not. But yes, it's a big plus for a drug if they have it. It also may be a big plus in the business world of medicine because one of the things that payers can use to zing a doctor is how many switches and treatment they do. Mark G. Lebwohl, MD: Yes. Patients are happy to continue giving them some of the medications to stay clear, I agree with what you said. I will say I was surprised by the IL-12/23 inhibitor finding but think about this. If you use PASI [Psoriasis Area and Severity Index] 75 as an end point. IL-12/23 inhibitor ustekinumab does quite well. And that effect is quite durable."

Video • Psoriasis

A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=494 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Study Reveals Racial Disparities in Treatment of Inflammatory Bowel Disease (Cleveland Clinic) - "Administered treatments included 5-aminosalicylates (5-ASAs), immunomodulators such as thiopurines and methotrexate, and other advanced therapies such as anti-tumor necrosis factor agents, ustekinumab, vedolizumab and tofacitinib. 'The findings were statistically significant for each of these medications so there was clearly a difference between medication use between Black patients and white patients,' Dr. Regueiro says."

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Pharmacokinetics of ABP 654, a proposed biosimilar to ustekinumab reference product (EADV 2022) - No abstract available

PK/PD data

Bruce Sands, MD, on IL-12/23 and IL-23 Inhibitors for IBD (HMP Global) - "Interleukin (IL)-12/23 and -23 inhibitors are effective options as first or second-line therapies, and are safer than anti-tumor necrosis factor (TNF) agents for many patients with inflammatory bowel disease (IBD), Bruce Sands, MD, said in his presentation....Ustekinumab, which is approved for both Crohn disease (CD) and ulcerative colitis (UC), blocks the p40 subunit present in both IL-12 and IL-23, Dr Sands explained."

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