Zarxio, the bio similar drug manufactured by Novartis AG (ADR) (NYSE:NVS) got approved by the US Food and Drug Administration, last Friday. Zarxio is basically a copy of Neupogen, manufactured by Amgen Inc. (NASDAQ:AMGN), however it is cheaper in price than the former drug. Thus, Zarxio attains the status of being the very first biosimilar drug that managed to get approved in US.
Both Neupogen and Zarxio contain essentially the same active compound in them. Various tests and clinical trials were conducted by the US Food and Drug Administration on the said drug in order to establish its efficacy. In all of these test trials, no significant changes were observed as such.
Up till now, there is no established system to give names to biosimilars, since Zarxio is the very first such drug to get approved by the FDA. However, until an appropriate naming develops, this biosimilar drug is probably going to be known as filgrastim-sndz.
The application for the approval of Zarxio was brought forth into the notice of FDA in the year 2014 and in the month of July. On 7th of January, 2015, the advisory committee of US Food and Drug Administration recommended this drug to get approved by the authority. This recommendation for approval was enough to make Amgen Inc. (NASDAQ:AMGN) stop dead in its tracks; since up till then its drug Neupogen had been enjoying the star-light. Amgen Inc.’s (NASDAQ:AMGN) block-buster oncology drug alone contributed into the gross revenue of the company by generating an income of $1.2 billion in the year 2014.
It is suspected that Zarxio would take away this popularity enjoyed by Neupogen, since both essentially contain the same active compound; whilst the former is also cheaper in price as compared to the latter.
In order to ensure that Neupogen continues in its successful venture, Amgen Inc. (NASDAQ:AMGN) filed a suit against Zarxio, in order to put a stop to its commercialization in the US market. Not only did Amgen Inc. (NASDAQ:AMGN) file a suit against the drug, rather Novartis AG (ADR) (NYSE:NVS) division, Sandoz, which came up with the drug was also sued. Court would attend to this hearing on thirteenth of March and most likely would come up with its final decision by the tenth of April.
In accordance with the Court’s decision, Novartis AG (ADR) (NYSE:NVS) has made a public announcement, stating that it wouldn’t launch Zarxio in the markets, even though it has been approved by the FDA, until the court gives its final decision on the tenth of April.
Zarxio was only approved once the FDA had carried out a thorough and extensive evaluation of the biosimilar drug. These drugs are basically cheaper imitation versions of biologic drugs which are obtained from living substances, and thus tend to be expensive. Yet, it is possible to manufacture other drugs that have a similar effect as that of the biologic drug. These imitation versions are called as biosimilar drugs. These drugs might resemble their biologic counter parts as far as the drug’s effect is concerned; yet, since these are not the completely accurate and hundred percent true copies, therefore their evaluation has to be done on an extensive scale, before they can ultimately be approved.