FDA Committee Recommends Approval of Neupogen Biosimilar

In a move that should lead to patients saving several hundred dollars in cancer care costs down the road, an FDA advisory committee has recommended that the FDA approve a biosimilar product for Neupogen.

Neupogen (filgrastim) is a recombinant human granulocyte colony-stimulating factor with a number of clinical uses, among them helping chemotherapy patients recover from neutropenia and avoid febrile neutropenia.

A biosimilar drug is to a biologic drug what a generic drug is to a brand-name drug. Because biologics are in fact biological agents, they can't be exactly reproduced the way a simple drug can. The answer is a biosimilar, which is a substance that exhibits no clinical difference than the biologic on which it is based.

Currently, there are no biosimilars approved for use in the United States. The biosimilar for filgrastim, made by Novartis and marketed elsewhere in the world as Zarzio, would be the first such biosimilar approved by the US FDA, provided the FDA follows the recommendation of its committee, which is usually does.

Assuming the FDA approves this biosimilar, it should result in patients paying less for this injection.

Source: Medscape

More Articles

More Articles

Amazon.com is pleased to have the Lymphoma Information Network in the family of Amazon.com associates. We've agreed to ship items...

The question ought to be what are myelodysplastic syndromes (MDS), since this is a group of similar blood and bone marrow diseases that...

Merkel Cell Carcinoma (MCC) is a very rare and aggressive skin cancer that usually develops when a person is in his or her 70s. It is...

Radiation Therapy Topics

...

At some point, the Seattle biotech company Cell Therapeutics Inc (CTI) should earn an entry in the Guinness Book of World Records for utter and...

Site Beginnings

This site was started as Lymphoma Resource Page(s) in 1994. The site was designed to collect lymphoma...

Three papers appearing in the journal Blood and pointing towards a regulator-suppressor pill could offer hope to blood cancer...

The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral...

The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with...

The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent...

According to a new study published in the Proceedings of the National Academy of Sciences, a team from the University of California, San...

Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...

New research suggests that frontline radioimmunotherapy...

Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of...

Sitemap