FDA OKs first biosimilar to prevent chemo-related infections

June 6, 2018

(HealthDay)—The first biosimilar drug to Neulasta has been approved by the U.S. Food and Drug Administration. Fulphila (pegfilgrastim) is approved for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy and have symptoms of febrile neutropenia.

A biosimilar drug, generally derived from a living organism, is approved based on that it is "highly similar" to a product that's already approved by the FDA, and that there are "no clinically meaningful differences" in safety, purity and potency, the agency said.

The most common side effects of Fulphila are pain in the bones, arms and legs. Less common but more serious include the possibility of spleen rupture, severe respiratory problems and , glomerulonephritis, leukocytosis, tumor growth, and "fatal sickle cell crises," the FDA said.

"We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from [price] competition to existing biologics once lawful intellectual property has lapsed on these products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

Fulphila is produced by Mylan, with U.S. headquarters in Canonsburg, Penn.

Explore further: 'BioSimilar' drug approved to treat certain types of anemia

More information: More Information

Related Stories

'BioSimilar' drug approved to treat certain types of anemia

May 15, 2018
(HealthDay)—Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit.

FDA approves first biosimilar drug in US

March 8, 2015
(HealthDay)—The U.S. Food and Drug Administration has approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

FDA approves biosimilar ogivri for breast, stomach cancers

December 4, 2017
(HealthDay)—Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as the nation's first biosimilar drug to treat certain breast and stomach cancers, the agency said Friday in a news release.

FDA approves first biosimilar drug for cancer

September 15, 2017
(HealthDay)—The first biosimilar drug to treat cancer has been approved by the U.S. Food and Drug Administration.

Novartis wins US OK for biosimilar version of Amgen's Enbrel

August 30, 2016
U.S. regulators have approved the first near-copy of Enbrel, drugmaker Amgen's pricey biologic medicine for treating rheumatoid arthritis and other immune system disorders.

FDA approves admelog for diabetes

December 12, 2017
(HealthDay)—Admelog (insulin lispro), a short-acting form of insulin, has been approved by the U.S. Food and Drug Administration to treat patients aged 3 years and older with either type of diabetes.

Recommended for you

Medicating distress: Risky sedative prescriptions for older adults vary widely

October 18, 2018
Despite years of warnings that older adults shouldn't take sedative drugs that put them at risk of injury and death, a new study reveals how many primary care doctors are still prescribing them, how often, and exactly where.

Medical management of opioid-induced constipation differs from other forms of condition

October 17, 2018
Traditional laxatives are recommended as first-line agents to treat patients with a confirmed diagnosis of opioid-induced constipation (OIC), according to a new guideline from the American Gastroenterological Association ...

Research assesses geographic distribution of new antibiotics following market introduction

October 16, 2018
There is a growing need for new antibiotics to help combat the looming threat of antimicrobial resistance. According to a new study conducted by researchers at the Center for Disease Dynamics, Economics & Policy (CDDEP) with ...

Health insurer policies may discourage use of non-opioid alternatives for lower back pain

October 5, 2018
Public and private health insurance policies in the U.S. are missing important opportunities to encourage the use of physical therapy, psychological counseling and other non-drug alternatives to opioid medication for treating ...

Opioid overdoses, depression linked

October 3, 2018
The link between mental health disorders and substance abuse is well-documented. Nearly one in 12 adults in the U.S is depressed, and opioid-related deaths are skyrocketing. As these numbers continue to climb, some mental ...

Do price spikes on some generic drugs indicate problems in the market?

October 1, 2018
A new USC study reports that sudden price spikes for some generic drugs—such as the recently reported increases of a decades-old generic heart medication and an antibiotic—are becoming more common.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.