Biosimilars | Specialty

The OncLive Biosimilars condition center page is a comprehensive resource for clinical news and expert insights on currently available and investigational biosimilars for reference drugs such as trastuzumab, rituximab, bevacizumab, and more. This page features news articles, interviews in written and video format, and podcasts that focus on updates with biosimilars and ongoing research with these types of agents.


First US Biosimilar Finally Reaches Market

September 3rd 2015

The first FDA-approved biosimilar, Zarxio, is now available for patients in the United States, following a series of lawsuits and court decisions.

Court Clears First US Biosimilar for Future Marketing

July 21st 2015

An appellate court ruled that the FDA-approved biosimilar Zarxio can be marketed in the United States after September 2, 2015.

Doctors Unwilling to Trust Similarity of Biosimilars

May 13th 2015

The FDA's approval in March of the first biosimilar drug for the US market has aroused much concern among physicians.

First FDA-Approved Biosimilar Blocked From Entering US Market

May 8th 2015

The first FDA-approved biosimilar, Zarxio, has been blocked from reaching US markets by an injunction from Amgen, the manufacturer of the G-CSF analog counterpart, Neupogen (filgrastim).

FDA Approves Zarxio as First US Biosimilar

March 6th 2015

The FDA has approved its first biosimilar, Zarxio, for all five its counterpart Neupogen's authorized indications.

Dawn of US Biosimilar Era Arrives

January 26th 2015

2015 has certainly got off to an exciting start in oncology!

ODAC Unanimously Supports Approval of First Biosimilar

January 7th 2015

In a 14-0 vote, the FDA's ODAC unanimously recommended approval of EP2006, a biosimilar version of filgrastim. If the FDA follows the recommendation, the drug would become the first biosimilar approved in the United States.

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