Teva from Israel has been pretty aggressive this last year with bringing generic drugs to market and is now testing the waters with Biosimilar drugs. Congress has not ruled on how this will work yet and one more thing we are still waiting to hear about. Also, Teva recently filed a lawsuit challenging Amgen on another issue.
Biosimilar drugs are in fact a hot topic now and different from generics in the fact that their formularies are different but very similar.
“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”
"The biotech industry deals with an ongoing basic education challenge: that our industry is not well-understood," says Gardner. "The science behind biotech is not well understood—the process of going through basic research to clinical trials to successfully delivering a product to patients worldwide. It's incredibly complicated, it takes a long time, and we have to show that process to elected leaders."
The product is already sold in Europe by Teva. In Europe there’s an established procedure already in place for biosimilar drug approvals unlike here in the US, and with the prices we pay for drugs here the stakes are a lot higher just from an economic standpoint, so a lot more to consider with the large sales Amgen has seen over the last number of years. BD
And now a friendly word from Teva:
* Teva files with FDA for white blood cell booster
* Teva's XM02 would compete with Amgen's Neupogen
* Already sold in Europe under TevaGrastim brand
NEW YORK, Dec 1 (Reuters) - Generic drugmaker Teva Pharmaceutical Industries Ltd(TEVA.TA) said on Tuesday it is seeking U.S. approval to market a biotechnology medicine to boost white blood cells that is similar to Amgen Inc's (AMGN.O) big-selling Neupogen.
The Teva drug, XM02, is already being sold under the brand name TevaGrastim in several European countries, where a pathway for approving generic versions of biotech drugs -- so-called biosimilars -- exists.
There are no such rules yet in place in the United States, so Israel-based Teva submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration, which treats XM02 as a new biotech medicine.
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.
Amgen, which has not yet had to face any generic competition for its medicines in the United States, reported combined worldwide sales of Neupogen and a related medicine Neulasta of $1.21 billion in the third quarter.