FDA To Review Teva Biosimilar of Amgen's Neupogen – Authority to Approve? Only Our Congress Knows

Last December Teva announced they were going to ask so now it looks like the FDA has given the ok to review. Due to lack of whatever you want to call it these days in Congress, there are no provisions where a generic version of a biotech drug (aka biosimilars) can be approved and the drug is viewed as a new drug application. Shoot they don’t seem to be able to figure out what budgets are these days so I am not holding my breath here on whether or not the biosimilars are completely understood or not.

Teva Asking FDA for Approval for Biosimilar Drug To Provide the Same Therapy as Amgen Product

Teva and Amgen also have some other issues at hand too with disputes on another drug where intellectual property is at the heart of things. Teva is a generic drug manufacturer from Israel and actually does have a couple of their own patents along the line.

Teva Suing Amgen Over Intellectual Property Infringement – Sensipar for Kidney Disease

This post was made almost a year ago, so you can see this pending legislation, discussion or what ever you want to call it at this point is also on the agenda for some decisions to be made one way or another. Merck on the other hand bought a biosimilar drug company last year.

Here Come the Bio Similar Drugs – Bill in Congress to allow Follow Me Provisions for the FDA

This company even tried to get a biosimilar approved by the FDA back in April of last year and received almost an immediate hands down, as the FDA until Congress once again can create some legislation, can’t grant approval and you just might guess this is one huge lobbied interest here with lots of money spent. Europe on the other hand has had a system in place for since 2006 for approving biosimilar drugs and just like generic drugs biosimilar means consumers pay less. BD

Genzyme gets biosimilar rejection

NEW YORK, Feb 2 (Reuters) - Generic drugmaker Teva Pharmaceutical Industries Ltd (TEVA.TA) said on Tuesday the U.S. Food and Drug Administration will review its application to sell a biotechnology medicine to boost white blood cells that is similar to Amgen Inc's (AMGN.O) big-selling Neupogen.

Teva said the FDA accepted its Biologics License Application for the medicine for which it has proposed the trade name Neutroval.

The Teva drug, XM02, is already being sold under the name TevaGrastim in several European countries, where a pathway for approving generic versions of biotech drugs -- so-called biosimilars -- is already in place.

No such pathway for generic biotech medicines exists yet in the United States. The U.S. Congress has been weighing creation of a process for companies to seek approval of generic biotech medicines as part of stalled healthcare reform legislation.

The Teva drug, like Amgen's Neupogen, is used to boost white blood cells in cancer patients undergoing some types of chemotherapy that can cause severe neutropenia, or low white blood cell count.

UPDATE 1-FDA to review Teva biosimilar of Amgen's Neupogen | Reuters