BioSimilars: FDA Panel Overwhelming Recommends Approval of Remicade BioSimilar, Congress Asks Tough Questions of FDA and CMS
Yesterday an FDA Advisory panel overwhelmingly recommended the Celltrion/Pfizer biosimilar Remsima 21-3 for approval for all the clinical indications for Jannsen's Remicade including (RA, AS, PsA, PsO, adult CD, pediatric CD, adult UC). The discussions were straight forward outlining just how similar the two products really were.
This is only the second biosimilar to get an advisory committee. But given the FDA's staff enthusiastic analysis of the clinical program and the advisory panels whole hearted validation for all the questions before the panel we can expect to see the flow of biosimilar applications and approvals...
Source: Policy and Medicine - February 10, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Biosimilar Sins of Omission
On Friday, FDA posted briefing documents ahead of the Feb. 9 meeting of its Arthritis Advisory Committee to discuss a BLA from Celltrion Inc. for its CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson. What's just as interesting is what's not in the package. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 8, 2016 Category: Pharmaceuticals Source Type: blogs
Do you know about behcet ’s syndrome?
I was reading some medical records the other day and came upon a condition known as Behcet’s syndrome. It is actually a rare disease, but more frequent and severe in patients from the Eastern Mediterranean and Asia. Inherited (genetic) and environmental factors, such as microbe infections, are suspected to be factors that contribute to the development of Behcet’s. The syndrome is not proven to be contagious. The symptoms of Behcet’s syndrome depend on the area of the body affected. Behcet’s syndrome can involve inflammation of many areas of the body. These areas include the arteries that supply blood to the body’...
Source: Nursing Comments - January 24, 2016 Category: Nursing Authors: Stephanie Jewett, RN Tags: Advice/Education Caregiving General Public Nursing/Nursing Students Patients/Specific Diseases Behcet's disease Behcet's syndrome cortisone genital ulcers inflammation mouth ucerations skin test Source Type: blogs
Do you know about behcet’s syndrome?
I was reading some medical records the other day and came upon a condition known as Behcet’s syndrome. It is actually a rare disease, but more frequent and severe in patients from the Eastern Mediterranean and Asia. Inherited (genetic) and environmental factors, such as microbe infections, are suspected to be factors that contribute to the development of Behcet’s. The syndrome is not proven to be contagious. The symptoms of Behcet’s syndrome depend on the area of the body affected. Behcet’s syndrome can involve inflammation of many areas of the body. These areas include the arteries that supply blood to the body’...
Source: Nursing Comments - January 24, 2016 Category: Nursing Authors: Stephanie Jewett, RN Tags: Advice/Education Caregiving General Public Nursing/Nursing Students Patients/Specific Diseases Behcet's disease Behcet's syndrome cortisone genital ulcers inflammation mouth ucerations skin test Source Type: blogs
Fab Mab? Look Beyond the Lab.
As we move ahead in the US with more biosimilars being submitted for approval – and for interchangeability – attention must be paid to patient outcomes. Case in point is research presented at the 2013 ACR/ARHP Annual Meeting that hasn’t as yet received the attention it deserves: Efficacy and Safety of CT-P13 (Infliximab Biosimilar) over Two Years in Patients with Ankylosing Spondylitis: Comparison Between Continuing with CT-P13 and Switching from Infliximab to CT-P13. Biosimilarity and measurement of efficacy is only one dimension. Attention must be paid to effectiveness relative to real-world patient outcomes data. ...
Source: drugwonks.com Blog - January 11, 2016 Category: Pharmaceuticals Source Type: blogs
From The Archives: Pharmaceutical Pricing
Welcome to “From the Archives,” a Health Affairs Blog series, where we take a timely topic and delve into the literature and history, from a Health Affairs angle, of course.
Harvoni, Sovaldi, Repatha, Daraprim. Four drugs that have made news for how much they cost patients and insurers. But in the scheme of pharmaceutical pricing—a nearly $400 billion dollar industry in the US that comprises 10 percent of health spending—they are just the tip of the iceberg.
This topic is so prominent that at Health Affairs we have devoted two issues to it over the past year: Specialty Pharmaceuticals and Biomedical Innovat...
Source: Health Affairs Blog - November 24, 2015 Category: Health Management Authors: Rachel Dolan Tags: Costs and Spending Drugs and Medical Technology Elsewhere@ Health Affairs Featured Insurance and Coverage Payment Policy biosimilars biotechnology From the Archives Pharma Research and Development small molecule drugs specialty dru Source Type: blogs
Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes New Identifiers For All Biologic Products
Yesterday, the Food and Drug Administration (FDA) released much anticipated guidance on how they plan to address nonproprietary naming of biologics and biosimilars. In it, FDA proposed that all biologics—both reference products and biosimilars—will share a core drug substance name and also a new “FDA-designated suffix” that is unique for each product. While brand-biologic manufacturers pressed FDA to ensure biosimilars carry unique names, the agency’s proposal in fact places a large burden on these manufacturers and prescribers to adopt the new naming model.
In March, FDA approved the fir...
Source: Policy and Medicine - August 28, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
PCSK9 inhibitor – Cardiology MCQ
The PCSK9 inhibitor which was recently approved by US FDA:
a) Evolocumab
b) Alirocumab
c) Infliximab
d) Abciximab
Correct answer: b) Alirocumab
Both evolocumab and alirocumab are PCSK9 inhibitors (proprotein convertase subtilisin/kexin type 9 inhibitors) [1]. PCSK9 inhibitors have been approved by US FDA (U.S. Food and Drug Administration) in those whom hypercholesterolemia is not controlled with diet and maximally tolerated statin treatment, if they have clinically manifest atherosclerotic disease like stroke or myocardial infarction [2]. Alirocumab can be given as a self administered subcutaneous injection once in tw...
Source: Cardiophile MD - July 31, 2015 Category: Cardiology Authors: Prof. Dr. Johnson Francis, MD, DM, FACC, FRCP Edin, FRCP London Tags: Cardiology MCQ DM / DNB Cardiology Entrance Featured Alirocumab hypercholesterolemia proprotein convertase subtilisin/kexin type 9 inhibitors Source Type: blogs
PatientsLikeMe Teams With FDA To Explore Patient-Reported Adverse Events
During last month's DIA Annual meeting in Washington, D.C., online patient community PatientsLikeMe announced a research collaboration with the Food and Drug Administration to determine how patient-reported data can give new insights into drug safety.
PatientsLikeMe has 350,000 members with 2,500 conditions who report on their real-world experiences online. Patients, family members, or others interested may search for a particular patients, conditions, and treatments. For example, view the page for Rheumatoid Arthritis/Crohn’s treatment Remicade to see all of the patient-entered information; similar information is...
Source: Policy and Medicine - July 9, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
June Man of the Month: Justin Vandergrift
Just in time for Father’s Day, meet Disruptive Women in Healthcare’s June Man of the Month, Justin Vandergrift. He gets our vote for “Dad Extraordinaire!”
When Justin and I met, he’d just spoken on a panel. In his remarks, he said his daughter didn’t need the best doctor. That stopped me. Cold. He said what? Did I hear that right? A Dad saying his daughter did not need the best doctor? What he said next answered my questions, but I wanted to learn more so we talked afterwards.
Justin, as you continued with your story about Kathryn, I found it compelling. The wisdom you shared was unlike anything I’d hea...
Source: Disruptive Women in Health Care - June 18, 2015 Category: Consumer Health News Authors: dw at disruptivewomen.net Tags: Man of the Month Source Type: blogs
To Spur Medical Innovation, Make Corporate Cheaters Pay
The past decade has seen a relatively constant rate of newly approved drugs every year. The number has even jumped in the past few years. Yet, despite such encouraging trends, we are actually facing a crisis in drug innovation today. That is because many of these new products do not offer substantial improvements over already available alternatives.
At the same time, novel and effective treatments for many diseases---both rare and common---remain elusive. For example, there is widespread concern over the lack of development of new antibiotics aimed at multidrug-resistant infections. Therapeutic innovation for central nerv...
Source: Health Affairs Blog - April 30, 2015 Category: Health Management Authors: Aaron Kesselheim Tags: Drugs and Medical Technology Health Policy Lab Medicaid and CHIP Medicare corporations Cost FDA legislation Marketing medical innovation Medical Innovation Act NIH Pharma price Source Type: blogs
Kickback Concerns Shouldn't Prohibit Manufacturers From Offering Assistance For Drugs Without Cheaper Alternatives
Infusion Association Asks For Kickback Safe Harbor For Expensive Biologics
Drug manufacturers routinely offer copayment coupons to reduce or eliminate the cost of patients' out-of-pocket payment for certain drugs. This financial assistance can be especially beneficial for patients who require expensive biologic therapies with large co-pays. Last year, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) released a report that such coupons may run afoul of the federal anti-kickback statute if they encourage the purchase of drugs paid for by government funded programs. Essential...
Source: Policy and Medicine - April 24, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Postpones Advisory Committee Review of Celltrion's Remicade Biosimilar
Celltrion will have to wait longer than expected for FDA's Advisory Committee to review its application for Remsima, a biosimilar for Johnson and Johnsons’ Remicade (infliximab). Yesterday, FDA announced that they would be postponing the meeting of the Arthritis Advisory Committee scheduled for March 17, 2015 where they were going to review the product.
View FDA's announcement here.
"The postponement is due to information requests pending with the sponsor of the application. A future meeting date will be announced in the Federal Register," states the Agency.
The A...
Source: Policy and Medicine - February 26, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Accepts Apotex's Neupogen Biosimilar Application: Raises Issues of How the Agency Will Address Exclusivity, Previous Warning Letters to Apotex
Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim, a biosimilar version of Amgen's Neupogen. The product was jointly developed with Intas Pharmaceuticals Ltd. Filgrastim is used to help cancer patients taking chemotherapy to fight infections and fever by boosting white blood cell count. This is the fifth application submitted through the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA), and the second biosimilar submitted by Apotex.
This latest Neupogen biosimilar application is not...
Source: Policy and Medicine - February 19, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Top stories in health and medicine, January 15, 2015
From MedPage Today:
CDC: Most Nosocomial Infections Fall. Rates of most major types of healthcare-associated infections have declined markedly in recent years.
RA Patients More Likely to Abandon Remicade. Rheumatoid arthritis (RA) patients were more likely to discontinue infliximab (Remicade) than adalimumab (Humira) and etanercept (Enbrel) in the first year of biologic treatment, and were more likely to stop adalimumab than etanercept.
Vyvanse Effective Option for Treating Binge Eating. Adults with binge eating disorder treated with lisdexamfetamine dimesylate (Vyvanse) saw improvements in binge eating behavior and its ...
Source: Kevin, M.D. - Medical Weblog - January 15, 2015 Category: Journals (General) Authors: MedPage Today Tags: News Infectious disease Psychiatry Rheumatology Source Type: blogs
