Novartis touts effectiveness, safety of autoimmune drug copies
ZURICH (Reuters) - Novartis on Friday touted safety and efficacy of its biosimilar copies of Johnson& Johnson's Remicade and Amgen Inc's Enbrel, citing a study it hopes will help convince doctors that switching from the original medicines is a viable alternative for treating autoimmune diseases. (Source: Reuters: Health)
Source: Reuters: Health - June 15, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis receives EU approval for biosimilar Zessly
ZURICH (Reuters) - Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. (Source: Reuters: Health)
Source: Reuters: Health - May 24, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

IBD Patients in Remission Can Safely Switch to Infliximab Biosimilar IBD Patients in Remission Can Safely Switch to Infliximab Biosimilar
Switching to CT-P13, an infliximab biosimilar, is safe and well tolerated in patients with IBD whose disease is in remission, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 13, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

EMA Committee Backs Remicade Biosimilar Zessly EMA Committee Backs Remicade Biosimilar Zessly
The committee favors marketing the infliximab biosimilar product Zessly for treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 23, 2018 Category: Consumer Health News Tags: Rheumatology News Alert Source Type: news

Switching From Infliximab to Biosimilar in Patients With IBD Switching From Infliximab to Biosimilar in Patients With IBD
Two infliximab biosimilars are currently available for the treatment of inflammatory bowel disease, at a much lower cost than infliximab innovator. Can patients be safely switched?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 20, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Symptoms Sufficient to Prompt Infliximab-dose Increases in Crohn's Disease Symptoms Sufficient to Prompt Infliximab-dose Increases in Crohn's Disease
Symptoms alone are as useful as a combination of symptoms, biomarkers and serum drug concentrations for determining the need for an increased dose of infliximab in patients with Crohn's disease (CD), according to results from a randomized trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 29, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

U.S. Appeals Court Invalidates J & J Patent on Remicade U.S. Appeals Court Invalidates J & J Patent on Remicade
A U.S. appeals court on Tuesday upheld a ruling that invalidated a crucial Johnson& Johnson patent on its blockbuster rheumatoid arthritis drug Remicade, limiting J&J ’ s ability to seek damages from Pfizer Inc over its launch of a lower-cost version of the drug.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 24, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

U.S. appeals court upholds ruling invalidating J & J patent on Remicade
(Reuters) - A U.S. appeals court on Tuesday upheld a ruling that invalidated a crucial Johnson& Johnson patent on its blockbuster rheumatoid arthritis drug Remicade, limiting J&J ’s ability to seek damages from Pfizer Inc over its launch of a lower-cost version of the drug. (Source: Reuters: Health)
Source: Reuters: Health - January 23, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Biosimilars, Biologics, New Legal Challenges for RA Treatments Biosimilars, Biologics, New Legal Challenges for RA Treatments
Early last winter, Pfizer launched its new rheumatoid arthritis treatment, Inflectra, pricing it 15 percent below the $4,000-a-dose wholesale price of Remicade, the drug for which it is a close copy.Kaiser Health News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 29, 2017 Category: Consumer Health News Tags: Rheumatology News Source Type: news

FDA approves new Pfizer biosimilar
Pfizer Inc. (NYSE:PFE) announced that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product. (Source: World Pharma News)
Source: World Pharma News - December 15, 2017 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

FDA Clears Another Remicade Biosimilar (Ixifi) FDA Clears Another Remicade Biosimilar (Ixifi)
The FDA has approved Pfizer's infliximab-qbtx (Ixifi) for all eligible indications for the US-licensed reference product.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2017 Category: Consumer Health News Tags: Rheumatology News Alert Source Type: news

Pfizer's second biosimilar of J & J's Remicade wins U.S. FDA approval
(Reuters) - The U.S. Food and Drug Administration approved Pfizer Inc's second biosimilar to Johnson& Johnson's blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - December 14, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade
December 13, 2017 -- Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 13, 2017 Category: Drugs & Pharmacology Source Type: news

Janssen drops U.S. lawsuit against Samsung Bioepis' Remicade copy
SEOUL (Reuters) - A unit of healthcare conglomerate Johnson& Johnson has dropped a lawsuit it filed to block a copy of its rheumatoid arthritis drug Remicade produced by South Korea's Samsung Bioepis Co Ltd from being sold in the United States. (Source: Reuters: Health)
Source: Reuters: Health - November 14, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

RA Efficacy, Safety Similar After Infliximab-to-SB2 Switch RA Efficacy, Safety Similar After Infliximab-to-SB2 Switch
Patients with RA who switched from infliximab to the biosimilar SB2 had ACR20 responses, adverse events, and immunogenicity profiles at 78 weeks similar to those in patients who continued infliximab.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 13, 2017 Category: Consumer Health News Tags: Rheumatology News Source Type: news

Long-term Studies Back Biologic-to-Biosimilar Switch Long-term Studies Back Biologic-to-Biosimilar Switch
Researchers in Europe compared clinical response, remission, and immunogenicity to determine whether switching between innovator infliximab and the CTP-13 biosimilar has any effect on outcomes.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 1, 2017 Category: Consumer Health News Tags: Gastroenterology News Source Type: news

IBD patients may stay healthier when doctors monitor medications before they lose efficacy
(Beth Israel Deaconess Medical Center) Proactive monitoring of blood levels of the therapeutic drug infliximab was associated with improved outcomes including lower risk of surgery and hospitalization. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 3, 2017 Category: International Medicine & Public Health Source Type: news

Pfizer Files Suit Over Remicade Contracts Pfizer Files Suit Over Remicade Contracts
Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 21, 2017 Category: Consumer Health News Tags: Rheumatology News Source Type: news

Surgery an Alternative to Infliximab for Some People With Crohn ’ s Disease Surgery an Alternative to Infliximab for Some People With Crohn ’ s Disease
Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 21, 2017 Category: Surgery Tags: General Surgery News Source Type: news

Pfizer files lawsuit against J & J ’s exclusionary contracts for Remicade
Pfizer has filed a lawsuit against Johnson& Johnson (J&J) in the US District Court for the Eastern District of Pennsylvania to ensure patients and providers have access to major, lower-cost biosimilar therapies. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 20, 2017 Category: Pharmaceuticals Source Type: news

Pfizer sues J&J, claims ‘anticompetitive practices’ over Remicade biosimilar
(Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - September 20, 2017 Category: Pharmaceuticals Source Type: news

Merck, Samsung Bioepis launch discounted U.S. Remicade alternative
NEW YORK/SEOUL (Reuters) - Merck& Co and South Korea's Samsung Bioepis Co Ltd said on Monday they have begun selling a less expensive alternative version of Johnson& Johnson's rheumatoid arthritis drug Remicade in the United States, a move that should accelerate price declines for the big-selling medicine. (Source: Reuters: Health)
Source: Reuters: Health - July 24, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Merck launches biosimilar version of J & J blockbuster Remicade
Merck and Co. Inc. on Monday became the second pharmaceutical company to launch a biosimilar version of Remicade, a drug that generates billions of dollars a year in sales for Johnson& Johnson. Renflexis, the Merck biosimilar product, was approved by the Food and Drug Administration on April 21 as a treatment for rheumatoid arthritis, Crohn's disease, ulcerative colitis and ankylosing spondylitis. It is the first medicine available in the United States under a global biosimilars develop ment and… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - July 24, 2017 Category: Health Management Authors: John George Source Type: news

Samsung Bioepis launches U.S. sales of Remicade biosmiliar
SEOUL (Reuters) - South Korea's Samsung Bioepis Co Ltd said it started U.S sales of its copy of Johnson& Johnson's rheumatoid arthritis drug Remicade on Monday - a move set to further undermine sales of the U.S. firm's top-selling drug. (Source: Reuters: Health)
Source: Reuters: Health - July 24, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Nonmedical Biosimilar Switch Results Surprise Investigators Nonmedical Biosimilar Switch Results Surprise Investigators
When the Danish government mandated a switch to the infliximab biosimilar, researchers had the perfect opportunity to study the effect on patients with rheumatologic inflammatory disease.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 30, 2017 Category: Consumer Health News Tags: Rheumatology News Source Type: news

Pregnancy and the Pharmacokinetics of Anti-TNF Agents in IBD Pregnancy and the Pharmacokinetics of Anti-TNF Agents in IBD
This study found that infliximab and adalimumab present differing effects.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 22, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Infliximab Induction Levels Predict IBD Treatment Failure Infliximab Induction Levels Predict IBD Treatment Failure
Lower infliximab trough levels during induction are associated with an increased risk of treatment failure during maintenance in patients with inflammatory bowel disease (IBD), researchers report.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - June 8, 2017 Category: Surgery Tags: Gastroenterology News Source Type: news

CT-P13, a Biosimilar of Anti-TNF-a for IBD CT-P13, a Biosimilar of Anti-TNF-a for IBD
Can CT-P13, a biosimilar of infliximab, be used safely in patients with inflammatory bowel diseases--and with comparable efficacy?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 25, 2017 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

UK CMA accuses Merck of breaking competition law with discount scheme
The UK Competition and Markets Authority (CMA) has accused US pharmaceutical company Merck Sharp& Dohme (MSD) of operating an anti-competitive discount scheme for its medicine Remicade. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 23, 2017 Category: Pharmaceuticals Source Type: news

UK watchdog accuses Merck of restricting biosimilar competition
Britain’s Competition and Markets Authority accused Merck‘s (NYSE:MRK) European unit, Merck Sharp & Dohme, of conducting an unfair discount scheme that it said was designed to restrict competition from biosimilar copies of the company’s drug, Remicade. Remicade is an antibody drug used to treat rheumatoid arthritis, ulcerative colitis and Chron’s disease. It was the 1st antibody drug to face competition from copycat versions in the European markets. Biosimilar drugmakers, including South Korea’s Celltrion, have launched discounted products that are “similar” enough to Remicade ...
Source: Mass Device - May 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Wall Street Beat Merck Source Type: news

UK competition watchdog accuses Merck of obstructing biosimilars
LONDON (Reuters) - Britain's competition watchdog on Tuesday accused Merck& Co of operating an anti-competitive discount scheme for its medicine Remicade, designed to restrict competition from so-called biosimilar copies of the drug. (Source: Reuters: Health)
Source: Reuters: Health - May 23, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Janssen Biotech goes to court to block launch of Remicade biosimilar
Jansen Biotech is not going to let a second biosimilar version of its blockbuster rheumatoid arthritis drug Remicade hit pharmacy shelves in the United States without a fight. The Horsham, Pa.-based subsidiary of Johnson& Johnson (NYSE: JNJ) has filed a patent infringement lawsuit with U.S. District Court in New Jersey to prevent Samsung Bioepis Co. Ltd. of South Korea from introducing Renflexis later this year. Biosimilar products are different from generic drugs, which are chemically identical… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 19, 2017 Category: American Health Authors: John George Source Type: news

Janssen files suit in U.S. to block sale of Samsung Bioepis' Remicade copy
SEOUL (Reuters) - A unit of healthcare conglomerate Johnson& Johnson filed a lawsuit to block a copy of its rheumatoid arthritis drug Remicade made by South Korea's Samsung Bioepis Co Ltd from being sold in the United States. (Source: Reuters: Health)
Source: Reuters: Health - May 19, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Inflammatory Arthritis Stable after Switch to Biosimilar Infliximab (CME/CE)
(MedPage Today) -- Disease activity similar 1 year after non-medical switching in Denmark (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - May 14, 2017 Category: Geriatrics Source Type: news

' Fears Allayed' by Latest Infliximab Biosimilar Evidence'Fears Allayed' by Latest Infliximab Biosimilar Evidence
The biosimilar is noninferior to the originator infliximab in patients with stable Crohn's disease, ulcerative colitis, and other inflammatory conditions, two studies demonstrate.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - May 9, 2017 Category: Gastroenterology Tags: Gastroenterology News Source Type: news

Infliximab Biosimilar: Getting Closer to Interchangeability (CME/CE)
(MedPage Today) -- New studies show no differences in patients who switch (Source: MedPage Today Dermatology)
Source: MedPage Today Dermatology - May 9, 2017 Category: Dermatology Source Type: news

Renflexis (Infliximab-abda Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 4, 2017 Category: Drugs & Pharmacology Source Type: news

Biosimilars Take Center Stage at Digestive Disease Week Biosimilars Take Center Stage at Digestive Disease Week
New phase 3 data comparing the efficacy and safety of infliximab with its biosimilar will be among the major research findings presented at Digestive Disease Week.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - May 3, 2017 Category: Gastroenterology Tags: Gastroenterology News Source Type: news

Samsung Bioepis receives FDA approval for Renflexis across all eligible indications
Samsung Bioepis has received the US Food and Drug Administration (FDA) approval for its biosimilar referencing Remicade (infliximab), Renflexis (infliximab-abda), across all eligible indications. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - April 24, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves Second Biosimilar to Remicade (FREE)
By Kristin J. Kelley Edited by Susan Sadoughi, MD, and Andr é Sofair, MD, MPH The FDA late last week OK'd the second … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - April 24, 2017 Category: Primary Care Source Type: news

FDA approves Samsung Bioepis' copy of J & J's Remicade: company
SEOUL (Reuters) - South Korea's Samsung Bioepis Co Ltd said on Saturday the U.S. Food and Drug Administration approved its copy of Johnson& Johnson's rheumatoid arthritis drug Remicade, the first drug developed by the Samsung Group unit approved in the United States. (Source: Reuters: Health)
Source: Reuters: Health - April 22, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves 2nd near-copy of Remicade for immune disorders
Federal regulators have approved another alternative version of Remicade, an expensive injected drug widely used for rheumatoid arthritis and other immune system disorders (Source: ABC News: Health)
Source: ABC News: Health - April 21, 2017 Category: Consumer Health News Tags: Health Source Type: news

FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
April 21, 2017 -- FDA today approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion. This is the second FDA-approved biosimilar to U.S.-licensed Remicade. A biosimilar product is a biological... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 21, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Clears Second Remicade Biosimilar (Renflexis) FDA Clears Second Remicade Biosimilar (Renflexis)
The FDA approves infliximab-abda (Renflexis, Samsung Bioepis) for multiple indications.FDA Approvals (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - April 21, 2017 Category: Dermatology Tags: Rheumatology News Alert Source Type: news

Dental implants in a young patient on Remicade infusions for cervical spondylitis?
I have a 39 year old male patient for dental implants who presents with cervical spondylosis and gets an infusion of infliximab (Remicaide) every 6 weeks. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - April 5, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

What Causes Uveitis?
Discussion Inflammation of the middle layer of the eye, or uvea, is termed uveitis. Uveitis can be divided into anterior, intermediate or posterior uveitis by involving the anterior (iris and ciliary body), intermediate (vitreous) or posterior (choroid and usually retina) compartments. Panuveitis involves all 3 compartments. Duration can also be used to classify uveitis. Acute is 6 weeks and> 3 months is chronic persistent uveitis. Episodic periods of inactivity and reactivity that last more than 3 months are called recurrent uveitis. A third way to characterize uveitis is if it is granulomatous or not. Uveitis increase...
Source: PediatricEducation.org - April 3, 2017 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Remicade for Rheumatoid Arthritis Treatment
(Source: eMedicineHealth.com)
Source: eMedicineHealth.com - March 27, 2017 Category: Journals (General) Source Type: news

AS: TNF Inhibitors Differ in Uveitis Risk (CME/CE)
(MedPage Today) -- Adalimumab and infliximab have lowest risk (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - March 18, 2017 Category: Geriatrics Source Type: news

Infliximab Biosimilar Safe and Effective for Inflammatory Bowel Disease Infliximab Biosimilar Safe and Effective for Inflammatory Bowel Disease
The infliximab biosimilar CT-P13 (Remsima) is safe and effective against inflammatory bowel disease (IBD), according to a systematic review and meta-analysis.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - March 14, 2017 Category: Surgery Tags: Gastroenterology News Source Type: news

Infliximab Use Not Tied to Malignancy in Pediatric IBD Infliximab Use Not Tied to Malignancy in Pediatric IBD
Immunosuppressive therapy with infliximab (Remicade, Janssen) for inflammatory bowel disease (IBD) in pediatric patients is not associated with increased risk of malignancy or hemophagocytic lymphohistiocytosis (HLH), according to a Janssen study.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - March 7, 2017 Category: Allergy & Immunology Tags: Gastroenterology News Source Type: news