Wednesday 20 March 2019 ,
Wednesday 20 March 2019 ,
Latest News
  • First funerals for NZ terror attack victims underway
  • Protests over Abrar’s death continue
  • 3 killed as train hits motorbike in Gopalganj
  • Dhaka ranks worst in Air Quality Index
  • Bhutan PM to visit Dhaka mid-April
21 May, 2018 00:00 00 AM

FDA approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the treatment of anemia

FDA
FDA approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the treatment of anemia

The U.S. Food and Drug Administration recently approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.

The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills.

Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drug’s uses and risks. In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions.

The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company.

Comments

Most Viewed
Digital Edition
More story
From the Editor

From the Editor

TThe skin is the largest organ of the human body covering the entire surface of the body. The skin is subject to a wide range of medical conditions and…
It’s not getting old that people fear, it’s getting old and lonely and disconnected

It’s not getting old that people fear, it’s getting old and lonely and disconnected

Ishould have suspected something about nursing homes when a veteran nurse retired in disgust, declaring that she could no longer see a birthday cake being…
Auto-transfusion

Auto-transfusion

Introduction: I have never seen auto-transfusion prior to my joining in Masaka Provincial Hospital, Uganda on transfer from New Mulago Teaching Hospital,…
Skin disoders

Skin disoders

Dr. rafiqul islam Skin disorders include a variety of medical problems associated with the skin. Three common forms of skin disorder are dermatitis, psoriasis…
Growing awareness of skin disease starts flurry of initiatives

Growing awareness of skin disease starts flurry of initiatives

Skin diseases in developing countries have a serious impact on people’s quality of life, causing lost productivity at work and school, and discrimination…
Scalp psoriasis: What you need to know to feel better

Scalp psoriasis: What you need to know to feel better

CHRISTINA DONNELLY    Psoriasis is an autoimmune disorder characterized by red, itchy, uncomfortable lesions that can affect the skin all over…
Diseases due to fungi

Diseases due to fungi

Thrush Thrush is a fairly common affection occurring in the mouth in bottle-fed infants. White patches are seen on the tongue and lining membrane of the…
Skin cancers

Skin cancers

Although skin cancers are not very common in Bangladesh, the effects of climate change have galvanized the incidence of such disorders around the world.…
Asthma and the weather

Asthma and the weather

What’s the Link? During an asthma attack, the airways in and out of your lungs narrow and your body makes extra mucus, both of which make it hard…
We must talk about abuse of children with autism

We must talk about abuse of children with autism

MAVERICK CRAWFORD III As a person with autism who suffered tremendous amounts of abuse as a child, I believe it is vital for the autism community to understand…
Public lecture on Emerging Public Health Challenges and Opportunities in Developing Countries held NSU campus, Dhaka

Public lecture on Emerging Public Health Challenges and Opportunities in Developing Countries held NSU campus, Dhaka

North South University (NSU) organized the special public lecture on Emerging Public Health Challenges and Opportunities in Developing Countries at the…
icddr,b supports development of a locally-produced rapid diagnostic kit for detection of cholera

icddr,b supports development of a locally-produced rapid diagnostic kit for detection of cholera

icddr,b scientists in partnership with Incepta Pharmaceuticals have  developed a  locally-produced dipstick named Cholkit for rapid, early and…
Failure to take statins leads to higher mortality rates

Failure to take statins leads to higher mortality rates

MANDY ERICKSON Patients who took statins less than 70 percent of the time had a 20 percent increase in mortality compared with those taking them at least…
Zinc could help as non-antibiotic treatment for UTIs

Zinc could help as non-antibiotic treatment for UTIs

New details about the role of zinc in our immune system could help the development of new non-antibiotic treatment strategies for bacterial diseases,…

Copyright © All right reserved.

Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Disclaimer & Privacy Policy
....................................................
About Us
....................................................
Contact Us
....................................................
Advertisement
....................................................
Subscription

Powered by : Frog Hosting