FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
Second Interchangeable Biosimilar Product Approved by Agency
SILVER SPRING, Md., Oct. 18, 2021 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inf... Biopharmaceuticals, Generics, FDA Boehringer Ingelheim, Cyltezo, Humira, adalimumab, biosimilar (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 18, 2021 Category: Pharmaceuticals Source Type: news
FDA Deems Adalimumab Biosimilar Cyltezo Interchangeable FDA Deems Adalimumab Biosimilar Cyltezo Interchangeable
The supplemental biologics license approval for Cyltezo makes the adalimumab biosimilar just the second biosimilar to be designated as interchangeable with its originator biologic product.Medscape Medical News (Source: Medscape FamilyMedicine Headlines)
Source: Medscape FamilyMedicine Headlines - October 18, 2021 Category: Primary Care Tags: Gastroenterology News Source Type: news
FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
The U.S. Food and Drug Administration today approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm) is now approved as interchangeable with (and may be substituted for) its reference product Humira (adalimumab). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 18, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA ® (ustekinumab) in Older Patients Across Approved Indications
SPRING HOUSE, PENNSYLVANIA, October 4, 2021 – Today, the Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis of STELARA® (ustekinumab) pooled safety data from 13 clinical studies across approved indications, showing rates of key safety events among adults 60 years and older treated with STELARA for up to five yearsa were similar to rates observed with placebo during the control phase of these trials.1,b Approved indications included adults with moderately to severely active Crohn’s disease (CD), moderately to severely active ulcerative colitis (UC), moderate to severe plaque psoriasis (P...
Source: Johnson and Johnson - October 4, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
European Agency Recommends Two New Adalimumab Biosimilars European Agency Recommends Two New Adalimumab Biosimilars
The Committee for Medicinal Products for Human Use gave a positive opinion for the approval of Hukyndra and Libmyris, each of which will have 15 indications.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 17, 2021 Category: Consumer Health News Tags: Rheumatology News Alert Source Type: news
VARSITY: Better Outcomes With Vedolizumab Than Adalimumab in UC VARSITY: Better Outcomes With Vedolizumab Than Adalimumab in UC
In patients with moderate to severe ulcerative colitis, treatment with vedolizumab leads to better histologic outcomes than treatment with adalimumab, according to findings from the VARSITY trial.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - September 3, 2021 Category: Gastroenterology Tags: Gastroenterology News Source Type: news
Adalimumab Biosimilar on Par With Original in Crohn's Disease Adalimumab Biosimilar on Par With Original in Crohn's Disease
For patients with moderate to severe active Crohn ' s disease, the adalimumab biosimilar BI 695501 from Boehringer Ingelheim proved as safe and effective as the original, AbbVie ' s Humira, in the phase-3 VOLTAIRE-CD study.Reuters Health Information (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - August 20, 2021 Category: Gastroenterology Tags: Gastroenterology News Source Type: news
Adalimumab Efficacious Adjunct to Surgery for Hidradenitis Suppurativa
WEDNESDAY, Aug. 18, 2021 -- For patients with moderate-to-severe hidradenitis suppurativa (HS), adalimumab is efficacious in conjunction with wide-excision surgery followed by secondary intention healing, according to a study published online Aug.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 18, 2021 Category: Pharmaceuticals Source Type: news
Certain Biologics May Boost Infection Risk in Psoriasis Patients Certain Biologics May Boost Infection Risk in Psoriasis Patients
Psoriasis patients who are new users of infliximab and adalimumab appear to be at a greater risk of serious infection than those beginning therapy with etanercept, according to French researchers.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - August 2, 2021 Category: Infectious Diseases Tags: Dermatology News Source Type: news
Adalimumab Safe and Effective in Children With Ulcerative Colitis Adalimumab Safe and Effective in Children With Ulcerative Colitis
Adalimumab is effective and well tolerated in children with moderate-to-severe ulcerative colitis, according to results of the ENVISION I study.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 6, 2021 Category: Consumer Health News Tags: Gastroenterology News Source Type: news
New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA ® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)
SPRING HOUSE, PENNSYLVANIA, June 2, 2021 – Today the Janssen Pharmaceutical Companies of Johnson & Johnson announced new efficacy and safety data for first-in-class TREMFYA® (guselkumab), including data from the first study evaluating a selective IL-23 inhibitor in adult patients with active PsA, all of whom had demonstrated inadequate response or intolerance to TNFi.1 In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRa patient population, which is often more diffic...
Source: Johnson and Johnson - June 2, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
SEAVUE: Ustekinumab vs Adalimumab for Crohn's Disease SEAVUE: Ustekinumab vs Adalimumab for Crohn's Disease
For biologic-naive adults with moderate to severe Crohn ' s disease, treatment with either adalimumab or ustekinumab leads to similar outcomes, according to results of the head-to-head SEAVUE trial.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - May 28, 2021 Category: Gastroenterology Tags: Gastroenterology News Source Type: news
Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn ’s Disease
SPRING HOUSE, PENNSYLVANIA, May 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced efficacy and safety data for STELARA® (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC),1-4including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.1 SEAVUE data showed treatment with STELARA demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve patients with mo...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Bimekizumab Tops Secukinumab for Plaque Psoriasis
MONDAY, April 26, 2021 -- For patients with moderate-to-severe plaque psoriasis, bimekizumab is noninferior and superior to secukinumab and adalimumab, according to two studies published online April 23 in the New England Journal of Medicine to... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 26, 2021 Category: Pharmaceuticals Source Type: news
Bimekizumab Tops Adalimumab for Plaque Psoriasis Bimekizumab Tops Adalimumab for Plaque Psoriasis
At week 16, 86.2% of those in the bimekizumab group had a PASI 90 response, compared with 47.2% in the adalimumab group.Medscape Medical News (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - April 23, 2021 Category: Dermatology Tags: Dermatology News Source Type: news
